2nd-line Treatment of Metastatic Colorectal Cancer

Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Study ID
NCT01532804
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab, oxaliplatin and 5FU combination — DRUG
    Bevacizumab 5 mg/kg administered as an iv infusion for 1h30, then for 1h and for 30 min. at the following cycles, respectively. Oxaliplatin 85 mg/m² administered as an iv infusion for 2h Elvorine 200 mg/m² administered as an iv infusion for 2h 5FU 400 mg/m2 bolus then 5FU 2,400 mg/m² iv infusion for 46h D1=D15 (12 cycles)
  • Bevacizumab, oxaliplatin and raltitrexed combination — DRUG
    Bevacizumab 7.5 mg/kg administered as an iv infusion for 1h30, then administered for 1h and 30 min at the following cycles, respectively. Oxaliplatin 130 mg/m² administered as an iv infusion for 2h Raltitrexed 3 mg/m² administered as an iv infusion for 15 min

Study Details

This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.

Key Dates

First listed
Feb 15, 2012
Start date
Jul 28, 2011
Status verified
Dec 2019
Primary completion
May 12, 2016
Completion
Jan 31, 2019

Study Design

Enrollment
83 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    FOLFOX6 + bevacizumab (D1=D15, 12 cycles)
  • Experimental: Arm B
    Raltitrexed + Oxaliplatin + Bevacizumab (D1=D21, 8 cycles)

Primary Outcome Measure

Disease-free survival [ Time Frame: 6 months ]

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