OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: 5-FU; Drug: bevacizumab [Avastin]; Drug: irinotecan; Drug: leucovorin; Drug: oxaliplatin

• Registration Number: NCT00940303
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Patients will receive up to 12 bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-06
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• adult patients, 18-70 years of age;
• metastatic colorectal cancer scheduled for standard first line chemotherapy;
• at least 1 measurable lesion;
• ECOG performance score of 0 or 1.

Exclusion Criteria

• prior chemotherapy for metastatic colorectal cancer;
• prior (neo)adjuvant chemotherapy/radiotherapy of a non-metastatic malignancy completed within 6 months prior to study entry;
• concomitant malignancies other CRC;
• history or evidence of CNS disease unrelated to cancer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	bevacizumab [Avastin]	-
1	irinotecan	-
1	5-FU	-
1	leucovorin	-
1	oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	assessed every 8 weeks up to week 102, 3-monthly during follow-up

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with NCI-CTC grade 3-5 adverse events; adverse events, laboratory parameters, ECOG performance status.	Throughout study, laboratory analyses every 2 weeks, ECOG assessment every 8 weeks
Overall survival; proportion of patients achieving R0 resectability; objective response rate (complete response [CR] and partial response [PR]); proportion of patients completing 12 cycles of chemotherapy.	assessed every 4 weeks up to week 102 and at the end of follow-up period