Treatment of advanced non-small cell lung cancer (NSCLC) with a biweekly schedule of irinotecan (I), paclitaxel, and cisplatinum (P): A phase II study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e19076-e19076
Author(s):  
M. Gonzalez ◽  
J. Rebollo ◽  
R. Rami ◽  
J. Belda ◽  
J. Farré ◽  
...  
Keyword(s):  
Phase Ii ◽  
Advanced Nsclc ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Metastatic Tumor ◽  
Complete Response ◽  
Time To Progression ◽  
Good Tolerance ◽  
Confirmatory Phase

e19076 Background: Irinotecan, paclitaxel (taxol, T), and cisplatinum are among the most active agents in the treatment of NSCLC, given alone as single agents or in combination. Based in previous data (Proc ASCO 2003 # 2816), we performed a confirmatory phase II study of the activity of a bi-weekly combination of I (120 mg/m2), T(60 mg/m2) and P (40 mg/m2) in advanced NSCLC. Methods: Forty-three patients (pts) (37 male, 6 female) with histologically proven IIIA-IV NSCLC were treated at our institution. Median age was 61 years (33–79). All pts were ECOG 0–2. 14 pts had locally advanced disease (8 IIIA, 6 IIIB) and 29 metastatic disease. Previous treatments included surgery (5 pts), radiotherapy (4 pts), chemotherapy (5 pts), surgery + radiotherapy (3 pts) and surgery + chemotherapy (2 pt). In three cases, treatment was administered as adjuvant after resection of a primary (2 cases) or a metastatic tumor (1 case). Results: A total of 299 courses were administered (median 6, range 2–14). Toxic episodes grade III-IV were neutropenic fever (10/299; 3.3%), anemia (1/299; 0.3%), asthenia (3/299; 1%), diarrhea (5/299; 17%), hemorrhagic colitis (1/299; 0.3%), mucositis (2/299, 0.6%), vomiting (4/299; 1.3%) and peripheral neuropathy (1/299; 0.3%). With a median follow-up of 72 months (9–97), 2 pts (4.6%) presented pathological complete response, 26 (60%) partial response, 11 (25%) stable disease and 1 pt progressed. Four partial responders were rendered free of disease after rescue surgery. Median time to progression was 6 months. Median survival was 10 months. The actuarial 2 and 5-year overall survival are 26% and 13% respectively. Conclusions: I, T and P at the referred doses can be safely administered in a bi-weekly basis, with a good tolerance and response rate in advanced NSCLC pts. No significant financial relationships to disclose.

A Phase II Study of Intravenous Azacitidine Alone in Patients with Myelodysplastic Syndromes NCT00384956.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1451-1451
Author(s):  
Richard Walgren ◽  
Crystal Dao ◽  
Frederieke Kreisel ◽  
Peter Westervelt ◽  
Camille Abboud ◽  
...  
Keyword(s):  
Median Time ◽  
Phase Ii ◽  
De Novo ◽  
Phase Ii Study ◽  
Study Drug ◽  
Complete Response ◽  
Subsequent Treatment ◽  
Open Label ◽  
Erythroid Response

Abstract Rationale: 5-Azacytidine (Aza), a DNA hypomethylating agent, has now been shown in 2 clinical trials involving high-risk MDS patients to provide a survival benefit over supportive/conventional care regimens. While one phase II study used a continuous 7-day IV infusion, Aza was administered subcutaneously (SQ) in most pre-approval studies. However, injection site reactions are not uncommon with SQ dosing, especially in thrombocytopenic patients. Aza given as a short intravenous (IV) infusion is anticipated to be efficacious from pharmacokinetic profiling and is FDA approved, but prospective efficacy data for short IV infusion are lacking. Study aim and design: To determine the efficacy of IV Aza when given as a short infusion, we have undertaken an open-label, single-arm, single-center phase II study of Aza in patients with MDS, either de novo or secondary, defined by FAB classification. Previously treated subjects were ineligible if they had already received Aza or decitabine. Treatment consisted of Aza 75 mg/m2 given as a 20 minute IV infusion once daily on Days 1–5 of a 28-day cycle. Response was evaluated by IWG 2000 criteria. After two cycles at the 75 mg/m2 dose, patients failing to achieve a CR were eligible for an increased dose of 100 mg/m2. After 6 cycles of therapy, patients must have demonstrated at least a hematologic improvement to continue on study. Study endpoints include determination of the complete response (CR) and partial response (PR) rates, and secondary endpoints examined the rates of hematological improvement, time to progression, and cytogenetic response. Results: Accrual began 8/17/06 with a target of 21 subjects. As of 7/31/07, 15 subjects have accrued with a median follow-up of 77 days (range 4 to 246). Subjects consisted of 9 males and 6 females with a median age of 69.6 yr (range 53 to 82). The median time from diagnosis is 213 days (range 0 days to 4 yr). By FAB criteria, subjects consist of 4 RA, 9 RAEB, 1 RAEB-t, and 1 CMML, and subjects are categorized by IPSS risk as 1 Low, 4 Int-1, and 10 Int-2. Two patients had therapy related MDS. The data remain preliminary with subjects having completed a mean of 3 cycles (range 1 to 6). None of the 5 subjects who have completed at least 4 cycles of therapy have achieved a CR. However, 2 (40%) of these subjects achieved a PR. Additionally, 1 (20%) patient had a major erythroid response, while another had a minor erythroid response. Median time to response was 2 months. Ten subjects remain on study, 1 patient withdrew due to progressive disease (in first week of therapy), and 4 deaths have occurred on study (2 due to sepsis, 1 each due to pneumonia and acute MI). No deaths were attributed to study drug. Common adverse events include nausea, emesis, and hematologic toxicities. Grade 2–3 nausea and grade 2–3 emesis each occurred in 5 subjects. Observed grade 3 or 4 hematologic toxicities included: anemia (n=7), thrombocytopenia (n=4), leukopenia (n=3), neutropenia (n=7), and febrile neutropenia (n=1). Hematologic toxicities have resulted in transient treatment delays (< 4 weeks) and dose reduction, but hematologic toxicities have not prevented subsequent treatment on study. Conclusions: Although follow-up is short for assessment of efficacy, this is the first prospective study to report on efficacy and toxicity of short infusional Aza in the treatment of MDS.

The VcR-CVAD Regimen Produces a High Complete Response Rate in Untreated Mantle Cell Lymphoma (MCL): First Analysis of E1405 – A Phase II Study of VcR-CVAD with Maintenance Rituximab for MCL.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1661-1661 ◽  
Author(s):  
Brad S Kahl ◽  
Hailun Li ◽  
Mitchell R Smith ◽  
Randy D. Gascoyne ◽  
Elisabeth Paietta ◽  
...  
Keyword(s):  
Phase Ii ◽  
Research Funding ◽  
Response Rate ◽  
Complete Response Rate ◽  
Phase Ii Study ◽  
Cell Lymphoma ◽  
Complete Response ◽  
Mantle Cell ◽  
Grade 3

Abstract Abstract 1661 Poster Board I-687 Introduction One approach to improving outcomes in Mantle Cell Lymphoma (MCL) is to incorporate newer targeted agents into standard chemotherapy regimens. As the proteasome inhibitor bortezomib (Velcade‘) achieved a 33% response rate in relapsed MCL, we hypothesized that the incorporation of Velcade (Vc) into a modified R-hyperCVAD chemotherapy backbone would result in a high complete response rate (CR). The new regimen, VcR-CVAD, was tested for safety and efficacy in a phase II study within the Wisconsin Oncology Network (UW) and demonstrated a CR rate of 77% (Kahl, ASH 2008). To determine the safety and efficacy of this regimen in a cooperative group setting, we initiated E1405: a phase II study of VcR-CVAD with maintenance rituximab (MR) for untreated MCL. Methods Eligible patients had histologically confirmed, previously untreated MCL, PS 0-2, and adequate end organ function. The treatment plan included: Velcade 1.3 mg/m2 days 1 and 4, rituximab 375 mg/m2 IV day 1, cyclophosphamide 300 mg/m2 IV over 3 hrs q 12 hrs X 6 doses days 1-3, doxorubicin 50 mg/m2 continuous infusion over 48 hrs days 1-2, vincristine 1 mg IV day 3, dexamethasone 40 mg po days 1-4. Cycles were repeated every 21 days for 6 cycles and all patients received G-CSF support. Patients achieving SD, PR, or CR received MR administered as 4 weekly treatments every 6 months for 2 years (protocol therapy). Patients had an option to receive high dose chemotherapy and autologous stem cell transplantation (off protocol) rather than MR. The primary endpoint of the trial was the CR rate, incorporating PET imaging, to VcR-CVAD induction therapy. Results Seventy-six eligible patients were enrolled between 5/07 and 10/08. Baseline characteristics include median age 62 (40-76), 59M:17F, 91% stage III/IV, and 39% with elevated LDH. Sixty-four patients (84%) completed VcR-CVAD induction therapy. Reasons for treatment discontinuation included PD (1), toxicity (4), patient preference (2), and other/unknown (5). Response information is available on 74 patients while data is outstanding on 2 patients. The ORR was 96% (73/76; 95% CI, 89%-99%), CR rate 75% (57/76; 95% CI, 64%-84%) and the PR rate 21% (16/76; 95% CI, 13%-32%). Six of the PR patients were coded as such because of protocol violations in which a post-treatment bone marrow biopsy or PET scan was not obtained. The CR rate in the 68 completely restaged patients was 84%. Forty-four patients proceeded to planned MR while 21 patients went off protocol to SCT consolidation. Median follow up is currently too short (9 months) to assess PFS and OS. The major toxicity of the treatment regimen was expected myelosuppression. Grade 3-4 non hematologic toxicities were rare. No patients developed grade 3-4 neuropathy. There were no treatment related deaths. Conclusion The VcR-CVAD induction produced high overall response (96%) and CR rate (75%) in a representative MCL patient population treated on a cooperative group protocol. The CR rate was high and comparable to the UW pilot study (77%). No episodes of severe painful peripheral neuropathy were reported using the reduced vincristine dosage and the overall toxicity profile was very acceptable. Longer follow up is needed to determine if the high CR rate will translate into improved PFS and OS. Disclosures Kahl: Genentech: Consultancy, Research Funding; Millennium: Consultancy, Research Funding. Off Label Use: Bortezomib as front line treatment in MCL. Smith:Genentech: Research Funding; Millennium: Research Funding. Advani:Seattle Genetics, Inc.: Research Funding. Horning:Genentech: Honoraria, Research Funding.

Long term follow up data of a phase II study of concurrent radiotherapy (RT) and gemcitabine (Gem) for patients with stage III or IV squamous cell carcinoma of the head and neck (SCCHN)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5574-5574
Author(s):  
P. M. Specenier ◽  
D. Van Den Weyngaert ◽  
C. Van Laer ◽  
J. Van Den Brande ◽  
M. Huizing ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Radical Neck Dissection ◽  
Locally Advanced ◽  
Tube Feeding ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Free Survival

5574 Background: RT with concurrent chemotherapy is superior to RT alone as treatment for locally advanced SCCHN. Gem is a potent radiosensitizer in vitro and in vivo and in addition has a good activity in SCCHN. Exploitation of these properties was the rationale for a single institution phase II study which evaluates the efficacy and toxicities of standard RT + weekly low dose Gem. Methods: Eligible were patients with primary inoperable or locally advanced stage III and IV SCCHN. Treatment: Planned RT was 70 Gy over 7 weeks with weekly Gem 100 mg/m2 within 2 hours prior to RT (Eisbrüch et al., ASCO, 1997, 1998). Presented endpoints are response rate (according to WHO), acute and late toxicity (according to NCICTC), disease free survival (DFS), local relapse free survival (LRFS) and overall survival (OS). Results: 26 patients (21 male, 5 female; performance status 0–2; no prior treatment) entered the study between November 1998 and September 2003. Median age was 56 years (range 48–78). Tumor sites were oropharynx (6), hypopharynx (17), glottis (1), paranasal sinus (1), unknown (1). Clinical stage was III (2) or IV (24). 7 Patients had T4N2 disease and 2 had T4N3 disease. Patients received a median of 7 Gem cycles (range 2–8) and a median of 70 Gy (66–84.75). 7 patients underwent radical neck dissection. Grade 3–4 acute toxicities included mucositis (22/26), dermatitis (18/26), pharyngitis and/or oesophagitis (21/26), pain (7/25), xerostomia (1/24), neutropenia (1/26) and anemia (1/26). 21/26 patients needed tube feeding and 21/26 needed to be hospitalized. After recovery from acute toxicity 6/23 could feed normally, 5/23 needed soft food, 5/23 were able to swallow liquid food and 2/23 required permanent tube feeding. Response was evaluable in 22 patients (11 CR, 11 PR). Intial relapse was at distant sites in 9/26 and local in 8/26. Median follow up of the patients still alive is 46 months. Median OS is 576 days, median DFS is 401 days, median LRFS is not reached. 7/26 remain free of disease more than 3 years after end of treatment. Conclusions: RT + Gem (100 mg/m2/week) is feasible but toxic. The combination is highly active in SCCHN and provides a good long term local control. [Table: see text]

Phase II study of pemetrexed, carboplatin, and thoracic radiation with or without cetuximab in patients with locally advanced unresectable non-small cell lung cancer: CALGB 30407

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7505-7505
Author(s):  
R. Govindan ◽  
J. Bogart ◽  
X. Wang ◽  
L. Hodgson ◽  
R. Kratzke ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Chemotherapy Regimen ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Small Cell ◽  
Small Cell Lung ◽  
Thoracic Radiation

7505 Background: Cisplatin, etoposide and concurrent thoracic radiation has remained the standard treatment for locally advanced unresectable non small cell lung cancer (NSCLC) over the past two decades. The Cancer and Leukemia Group B (CALGB) conducted a phase II study using a novel chemotherapy regimen administered in systemically active doses with thoracic radiation (CALGB 30407). We previously reported the preliminary safety results (ASCO 2008, abstract 7518). Methods: Eligible patients with previously untreated stage III NSCLC received thoracic radiation (70 Gy) along with carboplatin (AUC 5) and pemetrexed 500 mg/m2 on day 1 administered intravenously every 21 days for 4 cycles (arm A) or the same chemotherapy regimen with weekly cetuximab for 6 weeks concurrent with radiation (arm B). All patients received four additional cycles of pemetrexed (500 mg/m2 every 21 days) as consolidation therapy. The primary endpoint was the percentage of patients who lived longer than 18 months after starting initial treatment. We planned to study the regimen (s) further if the 18 month survival rates equaled or exceeded 55%. Results: Characteristics of the 99 eligible pts (48 in arm A and 51 arm B) enrolled from 09/05 to 1/08: male 62%, 22% were 70 yrs or older. The most common histological type was adenocarcinoma (46% in Arm A and 41% in Arm B). Updated toxicity data (grade 3 or greater, %) by arms (arm A/arm B) for 106 pts: neutropenia 40/47; febrile neutropenia 8/6, thrombocytopenia 36/34, nausea/vomiting 8/10, esophagitis 32/24, skin rash 2/21 and fatigue 22/17. The median follow up time is 17 months. Preliminary efficacy data by arms (arm A/arm B) for 99 pts: complete or partial response 73% (95% CI 59–83)/71% (95% CI 57–81%), median failure free survival (months) 12.9 (95% CI 8.6–18.0)/10.3 (95% CI 8.7–18.9); 18 month survival 57% (95% CI 41–79)/47% (95% CI 33–67) and median survival (months) 22.3/18.7. Conclusions: The combination of pemetrexed, carboplatin and thoracic radiation has met the protocol-specified criteria for further study. Although it does not appear that the addition of cetuximab confers additional benefit in this setting, further follow-up is necessary. [Table: see text]

A randomized, multicenter phase II study investigating additional weekly cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: Reporting on the efficacy.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7019-7019 ◽  
Author(s):  
Michel M van den Heuvel ◽  
Andrew D. Vincent ◽  
Wilma Uyterlinde ◽  
Joachim Aerts ◽  
Fredirike Koppe ◽  
...  
Keyword(s):  
Phase Ii ◽  
Concurrent Chemoradiotherapy ◽  
Advanced Nsclc ◽  
Phase Ii Study ◽  
Small Cell Lung Carcinoma ◽  
Locally Advanced ◽  
High Dose ◽  
Cell Lung Carcinoma ◽  
Multicenter Phase ◽  
Locally Advanced Nsclc

7019 Background: Modest benefits from concurrent chemoradiotherapy (CRT) in patients with locally advanced NSCLC warrant more effective treatment regimen. Cetuximab, a monoclonal antibody against the epidermal growth factor receptor has shown activity in NSCLC. Feasibility data and toxicity have been published previously. We report treatment outcome of a multicenter phase II study of the combination of high dose accelerated RT and daily dose cisplatin with or without weekly cetuximab. Methods: Patients with locally advanced NSCLC received accelerated RT (66 Gy in 24 fractions) and concurrent daily cisplatin (6 mg/m2) with (Arm A) or without (Arm B) additional weekly cetuximab (400 mg/m2 loading dose one week prior to the RT start followed by weekly 250 mg/m2). The Objective Local Response Control (OLRC) was determined at 6 and 24 weeks after treatment using response evaluation criteria in solid tumours criteria. Results: Between Feb 2009 and May 2011, 102 patients were included. Median follow-up was 13 months. Patients and tumor characteristics are shows in the Table. Stage distribution was: II (8%), IIIa (51%), and IIIb (40%). The CRT was well tolerated. The OLRC at 24 weeks was 79% in Arm A and 80% in Arm B. The one-year progression free survival and overall survival were 58% (45%-76%) and 76% (64%-91%) for Arm A and 49% (35%-68%) and 72% (58%-89%) for Arm B respectively. Conclusions: The addition of cetuximab to low dose cisplation CRT does not improve OLRC in an unselected patient cohort but data on longterm disease control and survival are to be awaited. [Table: see text]

Two-year follow-up of a phase II study on catumaxomab as part of a multimodal approach in primarily resectable gastric cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4095-4095 ◽  
Author(s):  
Carsten Bokemeyer ◽  
Karsten Ridwelski ◽  
Djordje Atanackovic ◽  
Dirk Arnold ◽  
Ewald Woell ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Multimodal Approach ◽  
En Bloc ◽  
Locally Advanced Gastric Cancer ◽  
Number Of Patients

4095^ Background: Perioperative chemotherapy (CT) has demonstrated as survival benefit in locally advanced gastric cancer (GC) in randomized trials. However, the overall cure rate is 30-40% and a significant number of patients are not able to receive the postoperative part of their CT regimen. In Europe, the trifunctional antibody catumaxomab is approved for the treatment of malignant ascites based on a pivotal trial which also included GC patients. A new multimodal approach combining neoadjuvant CT, followed by gastrectomy and intraperitoneal (i.p.) immunotherapy with catumaxomab was assessed in a single-arm multicenter phase II study. We here report 2-year follow-up data. Methods: GC pts (T2/T3/T4, N+/–, M0) received 3 cycles of neoadjuvant fluoropyrimidin/platinum-based CT followed by ’en-bloc’ R0-gastrectomy. Catumaxomab was administered i.p. as intraoperative bolus (10 µg) followed by 4 consecutive 3-hour infusions of 10-150 µg. Primary safety endpoint was the rate of predefined postoperative complications observed during 30 days after surgery. Key efficacy endpoints included disease-free (DFS) and overall survival (OS). Results: The original study data presented at the WCGC in 2011 (Schuhmacher et al.,Ann Oncol (2011) 22(suppl. 5)) showed that the primary endpoint was met and the described application regimen is safe. At time of surgery, 27.8% of patients were stage I, 27,8% of patients were stage II, 22,3% of patients were stage III and 14,8% of patients were stage IV as assessed according to pTNM measures. At 24 months 39/54 (safety analysis set) patients were still alife,14/54 were dead, (one patient lost to follow-up), 24/37 had no progression, only 13/37 patients relapsed (for 2 patients disease status was not recorded). At the 2 year cut off DFS was 56.4% (95% CI: 41–69%), OS was 75% (95% CI: 60–85%). Conclusions: Catumaxomab as part of a multimodal therapy in primarily resectable GC is a feasible option. The 2-year follow up efficacy results show promising data for DFS and OS in a cohort of locally advanced gastric cancer pts.

Phase II study of paclitaxel and capecitabine (PX) combination as neoadjuvant chemotherapy for unresectable locally advanced gastric cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15164-e15164
Author(s):  
Yoon Ho Ko ◽  
Sook Hee Hong ◽  
Sang Young Roh ◽  
Kyo Young Song ◽  
Eun Sun Jung ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Phase Ii ◽  
Metabolic Response ◽  
Phase Ii Study ◽  
Multidisciplinary Treatment ◽  
Locally Advanced ◽  
Complete Response ◽  
R0 Resection ◽  
Regional Lymph Nodes ◽  
Locally Advanced Gastric Cancer

e15164 Background: Unresectable locally advanced adenocarcinoma (AGC) of the stomach is associated with poor prognosis due to the lack of effective treatment. Neoadjuvant chemotherapy (NAC) has drawn more attention to the treatment of locally AGC in the current multidisciplinary treatment model. Paclitaxel and capecitabine (PX) has been used in palliative setting with good response rates but its role in a neoadjuvant setting is not well established. This phase II study was performed to evaluate the efficacy and safety of neoadjuvant PX chemotherapy in patients with unresectable locally AGC. Methods: Patients with AGC, clinically unresectable because of local invasion and/ or conglomerated regional lymph nodes (station 7, 8, and 9) metastasis on based on laparoscopic staging, were enrolled. PX consisted of paclitaxel 175 mg/m2 i.v. on day 1, and capecitabine 835 mg/m2 twice daily p.o. on days 1–14 every 21 days. After three cycles of NAC, patients with clinically resectable AGC underwent surgical resection. Results: This trial was stopped for poor accrual after 18 patients were enrolled; 50% patients had tumors located in the proximal third of the stomach. Seventeen patients finished three cycles of chemotherapy. The overall response rate was 41.2% (7/17 cases), of which 71.4% (10/14 cases) metabolic response. Fourteen (77.8%) of the 18 patients enrolled underwent surgery, and 12 (85.7%) had an R0 resection. Pathological complete response was observed in one (7.1%) of patients. Toxicity was mild to moderate and there were no treatment-related deaths and no major surgical complications. With a median follow-up of 28.6 months (range 6.4-38.4 months), the 2-year survival rate for all patients was 71.1%. Subgroup analysis found R0 resection (35.7 months vs. 20.6 months, P= 0.005) and patients with pathologic N downstaging (P < 0.001) to have improved overall survival. Conclusions: Neoadjuvant chemotherapy with PX shows promising results in unresectable locally AGC patients without increased morbidity and mortality. Neoadjuvant PX may permit a larger chance of curative resection in unresectable locally AGC patients.

Anti-epidermal growth factor receptor therapy in combination with chemoradiotherapy for the treatment of locally advanced anal canal carcinoma: Results of a phase II study with panitumumab (FFCD 0904).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3570-3570 ◽  
Author(s):  
Thomas Aparicio ◽  
Philippe Ronchin ◽  
Louis Bazire ◽  
Karine Le Malicot ◽  
Claire Lemanski ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Phase 1 ◽  
Locally Advanced ◽  
Growth Factor Receptor ◽  
Complete Response ◽  
Phase Iii ◽  
Radiation Dermatitis ◽  
Anal Squamous Cell Carcinoma ◽  
Advanced Tumor

3570 Background: Standard treatment of anal squamous cell carcinoma is 5-fluorouracil (5FU) and mitomycin C (MMC) based chemoradiotherapy (CRT). This phase II study studied the tolerance and complete response (CR) rate at 8 weeks of panitumumab (Pmab) combined with MMC-5FU based CRT. Methods: Patients with locally advanced tumor without metastases (Stage T2, T3 or T4, whatever N stage; Stage N1-N3 whatever T stage) were treated with two RT periods (45Gy in 5 weeks and a boost of 20Gy in 2 weeks) with concomitant CT sessions of 5FU/MMC at RT weeks 1 and 5. Pmab was administered on RT weeks 1, 3, 5 and 7 according to the doses defined by a previous phase 1.study (MMC: 10 mg/m² at J1 and J29; 5FU: 400 mg/m² from J1 to J4 and from J29 to J32, Pmab: 3mg/kg). The expected rate of CR at 8 weeks to continue in phase III was 80%. Results: Forty-five patients (male: 9 (20%), female: 36 (80%); median age: 60.1 [41.5-81]) were enrolled in 15 French centers. All patients but one completed the CRT. Median duration of CRT was 52 days [30-76].Fourteen patients had a RT interruption because of toxicity. Most common related grade 3-4 toxicities observed were digestive (51.1%), hematologic (lymphopenia: 73.4%; neutropenia: 11.1%), radiation dermatitis (28.8%) and asthenia (11.1%). On patient died because of mesenteric ischemia during the CRT (total dose: 36 Gy). In ITT analysis, the CR rate at 8 weeks after CRT was 66.7% [90%CI: 53.4-78.2]. Median follow-up was 16.2 months [14.1-18.2]. Overall survival, recurrence-free and colostomy-free survival at one year were 94.6% [95%CI: 75.8-98.7], 72.2% [95%CI: 55.0-83.7] and 78.2% [95%CI: 60.6 – 88.6] respectively. Six (13%) patients had a colostomy with abdomino-perineal amputation due to a tumour recurrence. Conclusions: Despite an acceptable tolerance, panitumumab in combination with CRT for locally advanced anal cancer failed to meet the expected CR rate to justify further clinical trials. Clinical trial information: NCT01581840.

Phase I/II Trial of Capecitabine, Oxaliplatin, and Radiation for Rectal Cancer

2003 ◽  
Vol 21 (16) ◽  
pp. 3098-3104 ◽  
Author(s):  
Claus Rödel ◽  
Gerhard. G. Grabenbauer ◽  
Thomas Papadopoulos ◽  
Werner Hohenberger ◽  
Hans-Joachim Schmoll ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Tumor Regression ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Sphincter Preservation ◽  
Phase Iii ◽  
Grade 3

Purpose: The purpose of this study was to establish the feasibility and efficacy of preoperative radiotherapy (RT) with concurrent capecitabine and oxaliplatin (XELOX-RT) in patients with rectal cancer. Patients and Methods: Thirty-two patients with locally advanced (T3/T4) or low-lying rectal cancer received preoperative RT (total dose, 50.4 Gy). Capecitabine was administered concurrently at 825 mg/m2 bid on days 1 to 14 and 22 to 35, with oxaliplatin starting at 50 mg/m2 on days 1, 8, 22, and 29 with planned escalation steps of 10 mg/m2. End points of the phase II study included downstaging, histopathologic tumor regression, resectability of T4 disease, and sphincter preservation in patients with low-lying tumors. Results: Dose-limiting grade 3 gastrointestinal toxicity was observed in two of six patients treated with 60 mg/m2 of oxaliplatin. Thus, 50 mg/m2 was the recommended dose for the phase II study. Toxicities observed at this dose level were generally mild, with only two cases of short-lived grade 3 diarrhea. Myelosuppression, mainly leukopenia, was restricted to grade 2 in 19% of patients. T-category downstaging was achieved in 17 (55%) of 31 operated patients, and 68% of patients had negative lymph nodes. Pathologic complete response was found in 19% of the resected specimens. Radical surgery with free margins could be performed in 79% of patients with T4 disease, and 36% of patients with tumors ≤ 2 cm from the dentate line had sphincter-saving surgery. Conclusion: Preoperative XELOX-RT is a feasible and well tolerated treatment. This regimen is proposed for phase III evaluation comparing standard fluorouracil-based therapy with XELOX chemoradiotherapy.

PO-0688: Concurrent CTRT (cCTRT) for locally advanced NSCLC followed by consolidation pemetrexed: a phase II study

2014 ◽  
Vol 111 ◽  
pp. S16
Author(s):  
C. Faivre-Finn ◽  
P. McCloskey ◽  
J. Helbrow ◽  
N. Bayman ◽  
P. Taylor ◽  
...  
Keyword(s):  
Phase Ii ◽  
Advanced Nsclc ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Locally Advanced Nsclc
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