A Study of Avastin (Bevacizumab) in Combination With mFOLFOX-6 or FOLFOXIRI in Patients With Metastatic Colorectal Cancer.

Roche

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Oxaliplatin; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-FU; Drug: bevacizumab [Avastin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00778102

MO18725

2007-007863-26

Details and patient eligibility

About

This 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresectable liver metastases receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment is until surgery, disease progression, unacceptable toxicity or patient refusal, and the target sample size is <100 individuals.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• unresectable liver metastasis secondary to cancer of colon or rectum;
• scheduled for standard first line chemotherapy;
• ECOG performance score of 0 or 1;
• condition feasible for major abdominal surgery after first line treatment.

Exclusion criteria

• diagnosis of metastatic disease >3 months prior to study entry;
• evidence of extrahepatic disease, diffuse peritoneal carcinosis or involvement of celiac lymph nodes;
• prior systemic or local treatment of metastatic disease;
• prior (neo)adjuvant chemotherapy/radiotherapy completed within 6 months prior to study entry;
• history or evidence of CNS disease unrelated to cancer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: bevacizumab [Avastin]

Drug: 5-FU

Drug: Leucovorin

Drug: 5-FU

Drug: Leucovorin

Drug: 5-FU

Drug: Oxaliplatin

2

Active Comparator group

Treatment:

Drug: bevacizumab [Avastin]

Drug: Irinotecan

Drug: 5-FU

Drug: Leucovorin

Drug: 5-FU

Drug: Leucovorin

Drug: 5-FU

Drug: Oxaliplatin