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

November 1, 2016 updated by: Hoffmann-La Roche

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
      • Berlin, Germany, 13347
      • Bochum, Germany, 44791
      • Celle, Germany, 29221
      • Celle, Germany, 29223
      • Dessau-Roßlau, Germany, 06847
      • Freiburg, Germany, 79106
      • Fulda, Germany, 36043
      • Hamburg, Germany, 20246
      • Hamburg, Germany, 22087
      • Hannover, Germany, 30171
      • Leer, Germany, 26789
      • Magdeburg, Germany, 39130
      • Magdeburg, Germany, 39120
      • Nürnberg, Germany, 90419
      • Stade, Germany, 21680
      • Villingen-Schwenningen, Germany, 78052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: assessed every 8 weeks up to week 102, 3-monthly during follow-up
assessed every 8 weeks up to week 102, 3-monthly during follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: assessed every 4 weeks up to week 102 and at the end of follow-up period
assessed every 4 weeks up to week 102 and at the end of follow-up period
Proportion of patients with NCI-CTC grade 3-5 adverse events; adverse events, laboratory parameters, ECOG performance status.
Time Frame: Throughout study, laboratory analyses every 2 weeks, ECOG assessment every 8 weeks
Throughout study, laboratory analyses every 2 weeks, ECOG assessment every 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

July 6, 2009

First Submitted That Met QC Criteria

July 15, 2009

First Posted (Estimate)

July 16, 2009

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML20514
  • 2008-001180-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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