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

Colorectal Cancer Clinical Trial

Official title:

An Open Label, Single-arm, Phase II Study to Evaluate the Efficacy and the Feasibility of Bevacizumab (Avastin) Based on a FOLFOXIRI Regimen Until Progression in Patients With Previously Untreated Metastatic Colorectal Carcinoma(OPAL-Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940303
• Other study ID #: ML20514
• Secondary ID: 2008-001180-11
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2009
• Last updated: November 1, 2016
• Start date: June 2009
• Est. completion date: February 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• 5-FU
3200mg/m2 continuous iv infusions, day 1 every 2 weeks
• bevacizumab [Avastin]
5mg/kg iv infusion, day 1 every 2 weeks
• irinotecan
165mg/m2 iv infusion, day 1 every 2 weeks
• leucovorin
200mg/m2 iv infusion, day 1 every 2 weeks
• oxaliplatin
85mg/m2 iv infusion, day 1 every 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		assessed every 8 weeks up to week 102, 3-monthly during follow-up	No
Secondary	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	No
Secondary	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	No