A phase I trial evaluating the safety and efficacy of weekly paclitaxel or cisplatin with electro-hyperthermia in patients with recurrent or persistent epithelial ovarian, fallopian tubal or primary peritoneal carcinoma (KGOG 3030).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e17032-e17032
Author(s):  
Kidong Kim ◽  
Dong-Hoon Suh ◽  
Jae Hong No ◽  
Yong Beom Kim ◽  
Jae Hoon Kim ◽  
...  
Keyword(s):  
Response Rate ◽  
Prospective Trial ◽  
Progression Free Survival ◽  
Median Number ◽  
Oncologic Outcomes ◽  
Weekly Paclitaxel ◽  
Peritoneal Carcinoma ◽  
Safety And Efficacy ◽  
Primary Peritoneal Carcinoma ◽  
Previous Regimen

e17032 Background: To evaluate the safety and efficacy of weekly paclitaxel or cisplatin with electro-hyperthermia in patients with recurrent or persistent epithelial ovarian, fallopian tubal or primary peritoneal carcinoma. Methods: This prospective trial employed ‘3+3 design’ with no dose escalation. Initially, patients were randomized to weekly paclitaxel (70mg/m2) or weekly cisplatin (40mg/m2) with electro-hyperthermia until three patients in each arm were evaluable for dose-limiting toxicities (DLTs). A cycle was 4 weeks long and paclitaxel or cisplatin was administered at day 1, 8, 15. Targeting tumor beds, electro-hyperthermia was administered semi-weekly (8 time/cycle) for 1 hour per session. DLT was defined as any adverse event possibly or probably related to therapy, that required intensive care or was not recovered to grade 2 or lower within 3 weeks. If ≤1 patient in an arm experienced DLT, additional 3 patients were enrolled to that arm. Unevaluable patients (n = 4) were replaced. Finally, 12 patients (6 in each arm) were evaluated for toxicities, response rate, progression-free survival (PFS) and overall survival (OS). Results: Nine patients had high grade serous histology. Median number of previous regimen was 2 (range 1- 5) and median treatment-free interval from previous chemotherapy was 6 months (range 0 – 27). Nine patients were platinum resistant or refractory. No DLT was observed. Four grade 3 toxicities were observed (nausea 1, hematologic 3) in cisplatin arm. Overall response rate was 42% (5/12), median PFS was 4.3 months (range 1.7 – 11.8), and median OS was over 13.8 months (range 3.9 – > 38.5). Conclusions: Both weekly paclitaxel and cisplatin with electro-hyperthermia are safe enough to be tested in further studies. Chemotherapy with electro-hyperthermia was seems to be an effective treatment strategy for recurrent or persistent epithelial ovarian, fallopian tubal or primary peritoneal carcinomas. No significant differences in oncologic outcomes and toxicities were observed between paclitaxel and cisplatin arms. Clinical trial information: NCT02344095.

scholarly journals Safety and Efficacy of Weekly Paclitaxel and Cisplatin Chemotherapy for Ovarian Cancer Patients with Hypersensitivity to Carboplatin

Cancers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 640
Author(s):  
Shinichi Tate ◽  
Kyoko Nishikimi ◽  
Ayumu Matsuoka ◽  
Satoyo Otsuka ◽  
Makio Shozu
Keyword(s):  
Ovarian Cancer ◽  
Progressive Disease ◽  
Renal Toxicity ◽  
Progression Free Survival ◽  
Median Number ◽  
Weekly Paclitaxel ◽  
Peritoneal Carcinoma ◽  
Free Survival ◽  
Safety And Efficacy ◽  
Carboplatin Hypersensitivity

Background: This study aimed to evaluate the safety and efficacy of weekly paclitaxel and cisplatin chemotherapy (wTP) in patients with ovarian cancer who developed carboplatin hypersensitivity reaction (HSR). Methods: We retrospectively investigated 86 patients with ovarian, fallopian tube, and peritoneal carcinoma who developed carboplatin HSR during previous chemotherapy (carboplatin and paclitaxel) at our institution between 2011 and 2019. After premedication was administered, paclitaxel was administered over 1 h, followed by cisplatin over 1 h (paclitaxel 80 mg/m2; cisplatin 25 mg/m2; 1, 8, 15 day/4 weeks). We investigated the incidence of patients who successfully received wTP for at least one cycle, treatments compliance, progression-free survival (PFS), and overall survival (OS). Results: The median number of wTP administration cycles was 4 (Interquartile Range IQR, 3–7), 71 patients (83%) successfully received wTP, and 15 patients (17%) developed cisplatin HSR. The efficacy of treatment was as follows: 55 (64%) patients completed the scheduled wTP, 9 (10%) patients discontinued due to HSR to cisplatin within 6 cycles, 1 (1%) patient discontinued due to renal toxicity (grade 2) at the 6th cycle, and 21 (24%) patients discontinued due to progressive disease within 6 cycles. The median PFS and OS after administration of wTP were 10.9 months (95% CI: 7.7–17.7) and 25.9 months (95% CI: 19.0–50.2), respectively. Conclusions: wTP was safe and well-tolerated in patients who developed carboplatin HSR.

Long-term safety and efficacy of pomalidomide (POM) with or without low-dose dexamethasone (LoDEX) in relapsed and refractory multiple myeloma (RRMM) patients enrolled in the MM-002 phase II trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8588-8588 ◽  
Author(s):  
David Samuel DiCapua Siegel ◽  
Paul Gerard Guy Richardson ◽  
Ravi Vij ◽  
Craig C. Hofmeister ◽  
Rachid C. Baz ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Progression Free Survival ◽  
Response Duration ◽  
Median Number ◽  
Open Label ◽  
Safety And Efficacy ◽  
Vein Thrombosis ◽  
Intent To Treat

8588 Background: MM-002 is a randomized, open-label, multicenter phase II trial evaluating the safety and efficacy of POM with or without LoDEX in advanced RRMM pts. Methods: Pts who had received ≥ 2 prior therapies, including lenalidomide (LEN) and bortezomib (BORT), and were refractory to their last treatment were randomized to POM+LoDEX (POM 4 mg/day, days 1–21 of a 28-day cycle; LoDEX 40 mg/week) or POM alone. End points included progression-free survival (PFS), response rate (according to EBMT criteria and investigator assessment), response duration, overall survival (OS), and safety. The efficacy outcomes are based on the intent-to-treat population (POM+LoDEX, n = 113; POM, n = 108). Results: The median number of prior therapies in each group was 5 (range 1–13). In the POM+LoDEX arm, 30 (27%) pts had high-risk cytogenetics, including del(17p13) and/or t(4p16/14q32). The overall response rate (≥ partial response) was 34% and 15% with POM+LoDEX and POM, respectively, with a median duration of 8.3 (95% CI: 5.8–10.1) and 8.8 (95% CI: 5.5–11.4) mos, respectively. At least minimal response was observed in 45% and 31% of pts, respectively. Median PFS was 4.6 (95% CI: 3.6–5.5) and 2.6 (95% CI: 1.9–2.8) mos with POM+LoDEX and POM, respectively, with a median follow-up of 16.0 and 12.2 mos. Median OS was 16.5 (95% CI: 12.4–18.5) and 13.6 (95% CI: 9.6–18.1) mos, respectively. The most common treatment emergent Gr 3/4 adverse events (AEs) reported in the safety population (n = 219) were neutropenia (44%), anemia (23%), thrombocytopenia (21%), and pneumonia (18%); there were no reports of Gr 3/4 peripheral neuropathy. The incidence of deep-vein thrombosis was low (2%). AEs were managed through dose reductions or interruptions, and supportive care with G-CSF (52%), RBC transfusions (47%), and platelet transfusions (17%). Discontinuations due to AEs were 10%. Conclusions: POM with or without LoDEX is clinically effective and generally well tolerated in RRMM pts who have received multiple prior treatments, including LEN and BORT. AEs were predictable and manageable. Updated data will be presented at the meeting. Clinical trial information: NCT00833833.

The safety and efficacy of weekly paclitaxel and cisplatin chemotherapy for patients with ovarian cancer who developed carboplatin hypersensitivity reaction in previous chemotherapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6058-6058
Author(s):  
Kyoko Nishikimi ◽  
Shinichi Tate ◽  
Ayumu Matsuoka ◽  
Makio Shozu
Keyword(s):  
Ovarian Cancer ◽  
Sodium Phosphate ◽  
Progression Free Survival ◽  
Weekly Paclitaxel ◽  
First Line ◽  
Peritoneal Carcinoma ◽  
Free Survival ◽  
Safety And Efficacy ◽  
Platinum Sensitive ◽  
Carboplatin Hypersensitivity

6058 Background: Carboplatin (CBDCA) hypersensitivity reactions (HSR) often occur in patients with ovarian cancer. Once CBACA HSR occurs, it is difficult to use platinum even though the patients had platinum-sensitive disease and consequently the survival of the patients cannot be prolonged. We had administered weekly paclitaxel and cisplatin (CDDP) chemotherapy (wTP) for patients with ovarian cancer who developed CBDCA HSR in previous chemotherapy. We investigated the safety and efficacy of wTP. Methods: We investigated 86 patients with ovarian, fallopian tube, and peritoneal carcinoma who developed CBDCA HSR in previous chemotherapy (paclitaxel/CBDCA) at our institution between 2011 and 2019. After premedication was administered, paclitaxel and sequentially CDDP were administered as one hour infusion, respectively (paclitaxel 80 mg/m2, CDDP 25 mg/m2; 1, 8, 15 day/4 weeks). Results: The median cycle of the previous chemotherapy of CBDCA was 8 (interquartile range [IQR], 6–11). The grade of CBDCA HSR was 1 in 57 (66%), 2 in 26 (30%), and, 3 in 1 (1%) patient(s). WTP was administered for the first line in 21 (24%), second line in 35 (41%) and third or more line in 30 patients (34%). The median cycles of wTP administration was 4 (IQR, 3–7). We observed that severe CDDP HSR did not occur in any patients and 15 patients (17.4%, grade 1, 10 patients; grade 2, 5) developed CDDP HSR. All CDDP HSR were successfully managed with infusion interruption and Hydrocortisone Sodium Phosphate administration. There was no relation between the grade of CBDCA HSR in the previous chemotherapy and the rate of CDDP HSR (p = 0.363). Progression-free survival and overall survival after administration of wTP were 10.9 months (95% CI: 7.7–17.7) and 25.9 months (95%Ci: 19.0–50.2), respectively. Conclusions: 71 patients (82%) who developed CBDCA HSR in previous chemotherapy were able to continue administration of wTP without CDDP HSR. WTP was safe and effective for the patients who developed CBDCA HSR. [Table: see text]

Third-line chemotherapy in platinum- and paclitaxel-resistant ovarian, fallopian tube, and primary peritoneal carcinoma patients

2004 ◽  
Vol 14 (5) ◽  
pp. 804-814 ◽  
Author(s):  
S. Tangjitgamol ◽  
H. T. See ◽  
S. Manusirivithaya ◽  
C. F. Levenback ◽  
D. M. Gershenson ◽  
...  
Keyword(s):  
Overall Survival ◽  
Stable Disease ◽  
Response Rate ◽  
Survival Duration ◽  
Cancer Center ◽  
Peritoneal Carcinoma ◽  
Primary Peritoneal Carcinoma ◽  
Study Results ◽  
Third Line ◽  
Line Chemotherapy

Ovarian carcinoma is a malignant disease with a high rate of recurrence, necessitating repeated chemotherapy treatments. We conducted a retrospective study in patients with platinum- and paclitaxel-resistant ovarian, fallopian tubes and primary peritoneal carcinoma patients treated at M.D. Anderson Cancer Center. We evaluated the responses, progression-free intervals, and overall survival duration of 51 patients after third-line chemotherapy treatment. The overall response rate was 16% (eight cases) with 2% complete response rate (one case) and 14% partial response rate (seven cases). Stable disease was achieved in 31% (16 cases). The progression-free intervals of 24 patients who had response and stable disease was 7.4 months (range, 1.4–18.4 months). The median overall survival of all patients was 15.8 months (95% CI, 8.1–23.4 months). The median survival duration of eight responders was not significantly different from that of 43 nonresponders, 18.9 months (95% CI, 2.4–35.4 months) versus 15.8 months (95% CI, 6.4–25.2 months), respectively (P = 0.73). In conclusion, third-line chemotherapy in our study results in a modest response and prolongation of progression-free interval without obvious impact on survival. The decision to utilize third-line chemotherapy will be a balance of the limited efficacy, toxicity of the agents, and the expertise of the clinician.

A phase II study of S-1 for previously treated small cell lung cancer (SCLC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e19074-e19074
Author(s):  
K. Kudo ◽  
F. Ohyanagi ◽  
A. Horiike ◽  
E. Miyauchi ◽  
I. Motokawa ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Performance Status ◽  
Single Agent ◽  
Progression Free Survival ◽  
Median Number ◽  
Ecog Performance Status ◽  
Treatment Regimens ◽  
Platinum Based Chemotherapy ◽  
Previously Treated

e19074 Background: S-1 is a novel oral 5-fluorouracil derivative that exhibits obvious activity against various tumor types including NSCLC. However, the effects of S-1 against SCLC have not been reported. The present phase II trial assesses the efficacy and safety of S-1 in previously treated SCLC patients. Methods: Eligible patients had pathologically documented SCLC that relapsed after platinum-based chemotherapy, ECOG performance status (PS) 0–2, and adequate bone marrow, kidney and liver function. Patients with untreated or symptomatic brain metastasis were excluded. Treatment comprised the oral administration of S-1 at 40 mg/m2 twice each day for 28 days every 6 weeks. The primary end point was the objective tumor response rate (RECIST). Secondary endpoints included progression-free survival and overall survival. Results: Twenty-six evaluable patients were enrolled (Simon's two-stage optimal design; α = 0.1; β = 0.1; P0 = 0.05; P1 = 0.25) with the following characteristics: male: female, 22/4; median age, 68 (33 - 79) y; PS0–1, n = 21; PS2, n = 5. The median number of prior treatment regimens was 2 (1–3). S-1 was administered for a mean of 1.3 cycles (1 - 5). One patient (3.8%) partially responded, 10 (38.5%) had stable and 15 (57.7%) had progressive disease. The overall response rate was 3.8% and the disease control rate was 42.3%. The median time to progression was 33 days. The median survival time was 8.0 months and the 1-year survival rate was 23%. This regimen was well tolerated. The common grade 3/4 toxicities included neutropenia (7.7%), leukopenia (7.7%), anemia (7.7%), hyponatremia (7.7%), rush (7.7%), infection (7.7%), and diarrhea (3.8%). None of the patients developed febrile neutropenia and no deaths were attributed to treatment. Conclusions: S-1 is well tolerated but has low activity as a single agent in previously treated patients with SCLC. No significant financial relationships to disclose.

A multicenter dose-finding study of irinotecan (CPT-11) based on UGT1A1 polymorphisms for metastatic colorectal cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14572-e14572
Author(s):  
Hirohiko Sato ◽  
Mitsuo Shimada ◽  
Nobuhiro Kurita ◽  
Takashi Iwata ◽  
Kozo Yoshikawa ◽  
...  
Keyword(s):  
Response Rate ◽  
Prospective Trial ◽  
Progression Free Survival ◽  
Dose Finding ◽  
Final Report ◽  
Severe Toxicity ◽  
Second Line ◽  
Free Survival ◽  
Gene Type ◽  
Wild Group

e14572 Background: Recent pharmacogenetic studies on irinotecan have revealed significant associations of UDP-glucuronosyltransferase 1A1 (UGT1A1) polymorphisms *28 and *6, the latter being specifically detected in East Asians resulting in severe toxicity such as severe diarrhea and neutropenia. It is necessary that the dose-finding trial that decided the optimal dose according to the gene polymorphism to draw out the maximum therapeutic effect while evading the side effect. Here, we present the final report of prospective trial of safety and efficacy about FOLFIRI ± bevacizumab (Bev) therapy according to each gene type of UGT1A1for Japanese patients with advanced CRC in second-line setting. Methods: Between September 2008 and March 2012, 59 patients were enrolled in this study. Grouping was defined as follows: wild group; both *28 and *6 were wild types, hetero group; *28 and either *6 was hetero type, and homo group; 28/*28 and *6/*6* or a both hetero types. In the 59 patients with advanced CRC treated with FOLFIRI ± Bev as a second line, wild and hetero groups were administered 150mg/m2 irinotecan, and homo group was 100mg/m2. The incidences of severe toxicities according to gene type of UGT1A1, the response rate and progression-free survival were investigated. Results: In the 59 patients, wild group was 28 (47%), hetero group was 26 (44.1%) and homo group was 5 (8.5%). 8 patients (29%) showed severe toxicities (grade 3 or more) in wild group, 5 patients (19%) in hetero group, 1 patient (20%) in homo group (P=0.71). Regarding the response rate, CR, PR, SD, PD was observed in 1 (4.0%), 1 (4.0%), 5 (20.0%) and 18 patients (72.0%), respectively in wild group, 0 (0.0%), 2 (8.3%), 5 (20.8%) and 17 patients (70.8%), in hetero group, 0 (0.0%), 0 (0.0%), 1 (20.0%) and 4 patients (80.0%), in homo group. The overall response rate (CR+PR) was 8.0% in wild group, 8.3% in hetero group, 0% in homo group (P=0.80). As for progression-free survival, the number of cycle to PD was 12.1 cycles (2-35 cycles) in wild group, 8.3 (2-20) in hetero group, 9.8 (6-14) in homo group (P=0.15). Conclusions: The dosages of 150mg/m2 irinotecan in hetero group, 100mg/m2 in homo group are safe and effective in FOLFIRI ± Bev therapy in the second line. Clinical trial information: UMIN000004773.

Phase II study of pazopanib with weekly paclitaxel in refractory urothelial cancer.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 294-294 ◽  
Author(s):  
Sandy Srinivas ◽  
Sujata Narayanan ◽  
Lauren Christine Harshman ◽  
Russell Kent Pachynski ◽  
Anthony P. Lam ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Performance Status ◽  
Progression Free Survival ◽  
Median Number ◽  
Upper Urinary Tract ◽  
Weekly Paclitaxel ◽  
Moderate Activity ◽  
Ecog Performance Status ◽  
Grade 3

294 Background: Currently, there are no standard treatments for relapsed or refractory urothelial carcinoma (UC). Discouraging results have been observed in trials evaluating established chemotherapeutics as single agents or in combination regimens. Paclitaxel has moderate activity when used alone and in combination in UC. Pazopanib is active in other solid tumors secondary to its potent anti-angiogenic effects. We report the results of a multi-center phase II study evaluating the combination of paclitaxel with pazopanib in refractory UC. Methods: Eligible patients (pts) had histologically confirmed UC, with disease that progressed on upto 2 chemotherapeutic regimens. Pazopanib (800 mg) was administered daily, with weekly paclitaxel (80mg/m2) for 3 weeks in a 28 day cycle. Treatment was continued until disease progression or unacceptable toxicity. The primary endpoint of the study was response-rate (RR) based on RECISTv 1.1 criteria. Secondary endpoints included safety, and progression free-survival (PFS). Results: From April 2010 to September 2014, 32 patients were enrolled. Median age was 67 years (29-89) and median ECOG performance status was 1 (0-2). 17 pts (54%) had UC of the upper urinary tract disease and 15(47%) had primary bladder tumors. All pts had multiple metastatic sites, including 9 (28%) with liver metastases. Median number of prior cytotoxic regimens was 2, and 50% were considered cisplatin responsive. Objective responses were observed in 58% with 3 (12%) complete responses (CR), and 12 pts (46%) with partial responses (PR). Another 9 (35%) acheived stable disease (SD). High grade toxicities included grade 3 hypertension (n=2), grade 3 fatigue (n=4), grade 3 thrombosis (n=2) and grade 4 neutropenia (n=2). Nearly half of the patients( n= 14 ) required growth factor support. Conclusions: Our phase II study combining paclitaxel and pazopanib demonstratedsignificant anti-tumor activity in relapsed/refractory UC. This combination is safe, effective and is worthy of evaluation in randomized phase 3 study. Clinical trial information: NCT01108055.

scholarly journals Pralatrexate in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results From the Pivotal PROPEL Study

2011 ◽  
Vol 29 (9) ◽  
pp. 1182-1189 ◽  
Author(s):  
Owen A. O'Connor ◽  
Barbara Pro ◽  
Lauren Pinter-Brown ◽  
Nancy Bartlett ◽  
Leslie Popplewell ◽  
...  
Keyword(s):  
T Cell ◽  
Response Rate ◽  
Cell Lymphoma ◽  
International Workshop ◽  
Progression Free Survival ◽  
Median Number ◽  
T Cell Lymphoma ◽  
Cell Transplant ◽  
Peripheral T Cell Lymphoma ◽  
Prior Therapy

Purpose Peripheral T-cell lymphoma (PTCL) is a poor prognosis subtype of non-Hodgkin's lymphoma with no accepted standard of care. This study evaluated the efficacy and tolerability of pralatrexate, a novel antifolate with promising activity. Patients and Methods Patients with independently confirmed PTCL who progressed following ≥ 1 line of prior therapy received pralatrexate intravenously at 30 mg/m2/wk for 6 weeks in 7-week cycles. Primary assessment of response was made by independent central review using the International Workshop Criteria. The primary end point was overall response rate. Secondary end points included duration of response, progression-free survival (PFS), and overall survival (OS). Results Of 115 patients enrolled, 111 were treated with pralatrexate. The median number of prior systemic therapies was three (range, 1 to 12). The response rate in 109 evaluable patients was 29% (32 of 109), including 12 complete responses (11%) and 20 partial responses (18%), with a median DoR of 10.1 months. Median PFS and OS were 3.5 and 14.5 months, respectively. The most common grade 3/4 adverse events were thrombocytopenia (32%), mucositis (22%), neutropenia (22%), and anemia (18%). Conclusion To our knowledge, PROPEL (Pralatrexate in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma) is the largest prospective study conducted in patients with relapsed or refractory PTCL. Pralatrexate induced durable responses in relapsed or refractory PTCL irrespective of age, histologic subtypes, amount of prior therapy, prior methotrexate, and prior autologous stem-cell transplant. These data formed the basis for the US Food and Drug Administration approval of pralatrexate, the first drug approved for this disease.

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