Control of cancer-associated inflammation and survival: Results from a prospective randomized phase II trial in gastric cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15584-e15584
Author(s):  
A. Reichle ◽  
A. Lugner ◽  
C. Ott ◽  
F. Klebl ◽  
M. Vogelhuber ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Phase Ii ◽  
Low Dose ◽  
Phase Ii Trial ◽  
Similar Response ◽  
First Line ◽  
Anti Inflammatory ◽  
Low Dose Chemotherapy ◽  
The Impact

e15584 Background: An angiostatic approach was used to assess the impact of anti-inflammatory therapy in combination with metronomic low-dose chemotherapy. Methods: A randomized multi-institutional phase II trial was designed to select metronomic chemotherapy (arm A: capecitabine 1 g orally twice daily for 14 days with one week break until tumor progression) or combined anti-inflammatory/angiostatic treatment (arm B: capecitabine as mentioned above plus etoricoxib 60 mg orally, day 1+, and pioglitazone 60 mg orally, day 1+) for further evaluation. Patients with refractory or progressive disease following any first-line therapy except capecitabine or frail were eligible. According to the one stage design, a sample size of 64 patients was calculated for the primary objective, improvement of response rate. Results: As similar response rates were observed (arm A/B 15/14%) after the accrual of 42 patients, the study was closed (n=20 (A), n=22 (B); median age 69 years (range 46 to 86ys); frail A/B n=9/11). Median progression- free survival for arm A/B was 3.0/2.9 months (P=0.878), and overall survival 5.0/6.1 months (P=0.778). In both treatment arms a significant decline of serum C-reactive protein (CRP) levels was observed within the first 4 to 6 weeks on treatment, A/B P= 0.01/0.04, respectively. CRP response > 50% from baseline was associated with a significantly improved overall survival in arm A/B (3.1 versus 11.0 months, P= 0.023/ 3.3 versus 7.1 months, P= 0.078) indicating an impact of inflammation-control on survival. WHO grade 3 (no grade 4) toxicities were reported in arm A/B in 20% and 23%, respectively, mostly due to hand-foot-syndrome. Conclusions: Metronomic low- dose chemotherapy in gastric cancer may induce anti-inflammatory response, but the chosen additional anti-inflammatory approach neither has impact on tumor-associated inflammation nor on response or survival rate. In a historical comparison, CRP-responder have similar outcome as patients treated with combination chemotherapy in first-line. No significant financial relationships to disclose.

scholarly journals Phase II Trial of Low-dose Paclitaxel and Cisplatin in Patients with Advanced Gastric Cancer

2005 ◽  
Vol 35 (12) ◽  
pp. 720-726 ◽  
Author(s):  
Keun-Wook Lee ◽  
Seock-Ah Im ◽  
Tak Yun ◽  
Eun Kee Song ◽  
Im il Na ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Low Dose ◽  
Phase Ii Trial

scholarly journals MONARCC: a randomised phase II study of panitumumab monotherapy and panitumumab plus 5-fluorouracil as first-line therapy for RAS and BRAF wildtype metastatic colorectal cancer: a study by the Australasian Gastrointestinal Trials Group (AGITG)

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ho Wai Derrick Siu ◽  
Niall Tebbutt ◽  
Lorraine Chantrill ◽  
Chris Karapetis ◽  
Christopher Steer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Overall Survival ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Tumour Response ◽  
Trial Registration ◽  
First Line ◽  
The Impact

Abstract Background Doublet chemotherapy in combination with a biologic agent has been a standard of care in patients with metastatic colorectal cancer for over a decade. The evidence for a “lighter” treatment approach is limited to mono-chemotherapy plus bevacizumab in the RAS unselected population. Anti-EGFR antibodies have activity as monotherapy or in combination with chemotherapy in RAS wildtype metastatic colorectal cancer; however their role in first-line treatment in combination with 5-fluorouracil monotherapy or when given alone has not been well studied. MONARCC aims to investigate this approach in an elderly population. Methods/design MONARCC is a prospective, open-label, multicentre, non-comparative randomised phase II trial. Eligible patients aged ≥70 with unresectable metastatic, untreated, RAS/BRAF wildtype metastatic colorectal cancer will be randomised 1:1 to receive panitumumab alone or panitumumab plus infusional 5-fluorouracil. RAS and BRAF analyses will be performed in local laboratories. Comprehensive Health Assessment and Limited Health Assessments will be performed at baseline and at 16 weeks, respectively, to assess frailty. The Patient Symptom Questionnaire and Overall Treatment Utility are to be undertaken at different timepoints to assess the impact of treatment-related toxicities and quality of life. Treatment will be delivered every 2 weeks until disease progression, unacceptable toxicity (as determined by treating clinician or patient), delay of treatment of more than 6 weeks, or withdrawal of consent. The primary end point is 6-month progression-free survival in both arms. Secondary end points include overall survival, time to treatment failure, objective tumour response rate as defined by RECIST v1.1 and safety (adverse events). Tertiary and correlative endpoints include the feasibility and utility of a comprehensive geriatric assessment, quality of life and biological substudies. Discussion MONARCC investigates the activity and tolerability of first-line panitumumab-based treatments with a view to expand on current treatment options while maximising progression-free and overall survival and quality of life in molecularly selected elderly patients with metastatic colorectal cancer. Trial registration Australia New Zealand Clinical Trials Registry: ACTRN12618000233224, prospectively registered 14 February 2018.

The impact of cetuximab on the capecitabine plus oxaliplatin (XELOX) combination in first-line treatment of metastatic colorectal cancer (MCC): A randomized phase II trial of the Swiss Group for Clinical Cancer Research (SAKK)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3551-3551 ◽  
Author(s):  
M. Borner ◽  
W. Mingrone ◽  
D. Koeberle ◽  
R. Von Moos ◽  
D. Rauch ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
High Response ◽  
Line Treatment ◽  
First Line ◽  
Clinical Cancer Research ◽  
Grade 3 ◽  
The Impact ◽  
First Line Treatment

3551 Background: XELOX is a valuable alternative to continuous infusion FOLFOX type regimens in the treatment of MCC (Borner et al, JCO 2002, 1759). Cetuximab is an EGFR antibody, which has been shown to improve the efficacy of chemotherapy. A phase II study in first-line treatment of MCC has demonstrated a high response rate combining cetuximab with FOLFOX (Tabernero et al, Proc ASCO 2004, 3512). Methods: Multicenter, randomized two-arm phase II trial: OXA 130 mg/m2 day 1 and oral CAP 1000 mg/m2 bid days 1–14 every 21 days alone or in combination with cetuximab 250 mg/m2 weekly after a loading dose of 400 mg/m2. Treatment was limited to a maximum of 6 cycles. With 37 patients in each arm, the power was 90% to select the truly better arm if the true between-arm difference in response rate (RECIST) is at least 15%. The study was open for accrual until October 2005. Results: We present here the results of 74 patients included in the study. In 67 patients the first response data are available (investigators’ assessment after 3 cycles). The two arms are well balanced for relevant patient, disease and treatment characteristics. The study treatment was well tolerated with grade 3/4 toxicities in < 10% of the cycles in each arm. The frequency of side effects was balanced, but with more frequent skin toxicity in the cetuximab arm (6% versus 0% grade 3/4). Conclusions: Cetuximab seems to positively interact with XELOX in terms of efficacy but not toxicity. The cetuximab/XELOX combination appears to be a valuable option in first-line treatment of MCC especially if high response rates are a primary objective. This trial was supported in part by Merck KGaA and Sanofi-Aventis Switzerland. [Table: see text] No significant financial relationships to disclose.

A phase II trial of low-dose nab-paclitaxel for patients with previously treated or recurrent advanced gastric cancer (OGSG1302).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 350-350
Author(s):  
Masashi Hirota ◽  
Shigeyuki Tamura ◽  
Hirokazu Taniguchi ◽  
Atsushi Takeno ◽  
Hiroshi Imamura ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Peripheral Neuropathy ◽  
Adverse Events ◽  
Phase Ii ◽  
Low Dose ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Dose Intensity ◽  
Relative Dose Intensity ◽  
Grade 3

350 Background: Paclitaxel is a key drug in second-line chemotherapy for advanced or recurrent gastric cancer (AGC) and nanoparticle albumin-bound paclitaxel (nab-PTX) is also widely used in Japan. A previous phase II trial in Japan showed the effectiveness of nab-PTX (260 mg/m2) administered every 3 weeks (q3w) in patients with AGC with a response rate (RR) of 27.8%; however, toxicity was major concern with grade ≥3 neutropenia (49.1%) and peripheral neuropathy (23.6%). To solve this problem, we investigated the efficacy and safety of low-dose q3w nab-PTX regimen in AGC. Methods: Eligibility requirements included: aged ≥20 years, HER2-negative, histologically confirmed, unresectable or recurrent gastric adenocarcinoma, one or more prior chemotherapy containing fluoropyrimidine regimens, presence of measurable lesion(s) according to RECIST ver. 1.1, ECOG PS of 0–2, and adequate organ function. Nab-PTX was administered at a dose of 220 mg/m2 every 3 weeks. The primary endpoint was the RR. Secondary endpoints were overall survival (OS), progression-free survival (PFS), disease-control rate (DCR), incidence of adverse events, relative dose intensity and proportion of patients who received subsequent chemotherapy. Results: Thirty-three patients were enrolled from 10 institutions in Japan. Of the 32 patients treated with protocol therapy, RR (CR, PR) was 3.1% (95% CI, 0–16.2%), which was not reached the protocol-specified threshold (p = 0.966). DCR (CR, PR, SD) was 37.5% (95% CI, 21.1–56.3%), median OS and PFS were 6.3 months (95% CI, 4.4–14.2) and 2.2 months (95% CI, 1.8-3.1). Relative dose intensity was 97.8% (215 mg/m2). 62.5% of patients received subsequent chemotherapy. Most common grade ≥3 adverse events were neutropenia (38%), anemia (13%), fatigue (19%), anorexia (16%), and peripheral neuropathy (13%). Conclusions: Low-dose regimen of q3w nab-PTX was slightly less toxic, although it did not demonstrate the same effect as the original regimen in response rate. Therefore, it is not recommended for AGC in second or later line setting. Clinical trial information: UMIN 000012701.

A phase II trial of bevacizumab with dacarbazine and daily low-dose interferon-α2a as first line treatment in metastatic melanoma

2010 ◽  
Vol 20 (4) ◽  
pp. 318-325 ◽  
Author(s):  
Pia P. Vihinen ◽  
Micaela Hernberg ◽  
Meri-Sisko Vuoristo ◽  
Kristiina Tyynelä ◽  
Marjut Laukka ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Phase Ii ◽  
Low Dose ◽  
Phase Ii Trial ◽  
Line Treatment ◽  
First Line ◽  
Interferon Α2a ◽  
First Line Treatment
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