A Phase 2 interventional study of FOLFIRI 1-Bevacizumab and fluorouracil in Colorectal Cancer, sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group. Terminated at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-06-04.
Sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated irinotecan hydrochloride PEP02, irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving liposome-encapsulated irinotecan hydrochloride PEP02 together with leucovorin calcium and fluorouracil is more effective than giving irinotecan hydrochloride together with leucovorin calcium and fluorouracil as second-line therapy in treating patients with metastatic colorectal cancer.
PURPOSE: This randomized phase II trial is studying liposome-encapsulated irinotecan hydrochloride PEP02 given together with leucovorin calcium and fluorouracil to see how well it works compared with giving irinotecan hydrochloride together with leucovorin calcium and fluorouracil as second-line therapy in treating patients with metastatic colorectal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified, in terms of prognosis, according to treatment center, prognostic score (ECOG performance status [PS] 0 and normal LDH value vs ECOG PS > 1 and/or LDH > 1 times upper limit of normal), and time to progression after first-line therapy (≥ 9 months vs \< 9 months). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients are assigned to either the FOLFIRI 1 or Modified FOLFIRI 3 treatment groups according to the investigator's discretion in combination with bevacizumab
Blood samples are collected periodically for pharmacogenetic analysis of UGT1A family polymorphisms. Quality of life is assessed by using a generic scale EQ-5D and the QLQ-C30 questionnaire at baseline and after courses 4 and 8.
After completion of study treatment, patients are followed up at day 30 and then every 2-3 months thereafter.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's enrollment of 55 is below the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →GERCOR - Multidisciplinary Oncology Cooperative Group is the lead sponsor of 76 studies on the registry; 12 are open to participants now.
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DISEASE CHARACTERISTICS
Histologically proven adenocarcinoma of colon or rectum
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
FOLFIRI 1-Bevacizumab: Day 1 H0 : Bevacizumab 5 mg/kg, 30-90 min infusion H+1: Irinotecan 180 mg/m² in 250 ml NaCl 0.9%, 1h infusion Folinic Acid 400 mg/m² (l + d racemic form, or l form 200 mg/m²) over 2h H + 3: 5-FU bolus 400 mg/m², 15 min infusion H + 3.5: 5-FU continuous infusion 2400 mg/m² 46-h infusion End of cycle: day 14 modified FOLFIRI3-Bevacizumab H0 :Bevacizumab 5 mg/kg, 30-90 min infusion H+1:Irinotecan 90 mg/m² in 250 ml NaCl 0.9%, 1h infusion H+1: Folinic Acid 400 mg/m² (l + d racemic form, or l form 200 mg/m²) 2-h infusion H + 3: 5-FU continuous infusion 2400 mg/m² 46-h infusion Day 3 (H+49) H0 Irinotecan 90 mg/m² in 250 ml NaCl 0.9%, 1h infusion End of cycle: day 14
Drug: FOLFIRI 1-Bevacizumab · Drug: fluorouracil · Drug: irinotecan hydrochloride · Drug: leucovorin calcium · Drug: Bevacizumab
Day 1 H0 :Bevacizumab 5 mg/kg, 30-90 min infusion H +1 :PEP02 80 mg/m² , 1h30 infusion. The infusion time could be reduced to 1h from cycle 2 if no acute infusion reaction has occured in cycle 1. H +1 : Folinic Acid 400 mg/m² (l + d racemic form, or l form 200 mg/m²) , 2-h infusion H +3 : 5-FU continuous infusion 2400 mg/m² 46-h infusion End of cycle: day 14
Drug: fluorouracil · Drug: leucovorin calcium · Drug: liposome-encapsulated irinotecan hydrochloride PEP02 · Drug: Bevacizumab
Tumor response
Assessment of tumor response at 2 month after randomization by RECIST 1.1
Time frame: at 2 months
Safety
assessment of adverse events and toxicity according NCI CTC v4.0
Time frame: before each 2-weeks cycles
Progression-free survival
Time frame: the time from the date of randomization to the date of progressive disease (RECIST criteria) or death (any cause)
Overall survival
Time frame: from the date of randomization to the date of patient death, due to any cause, or to the last date the patient was known to be alive
Quality of life
Quality of life will be assessed by using a generic scale EQ-5D and the QLQ-C30 questionnaire
Time frame: at baseline, cycle 4, and cycle 8
Correlation of UGT1A family polymorphism and the toxicity of liposome-encapsulated irinotecan hydrochloride PEP02 or irinotecan hydrochloride
Time frame: at baseline
This study is terminated, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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GERCOR - Multidisciplinary Oncology Cooperative Group