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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00940303
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: 5-FU Drug: bevacizumab [Avastin] Drug: irinotecan Drug: leucovorin Drug: oxaliplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : June 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: assessed every 8 weeks up to week 102, 3-monthly during follow-up ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00940303

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, 39120
Magdeburg, Germany, 39130
Nürnberg, Germany, 90419
Stade, Germany, 21680
Villingen-Schwenningen, Germany, 78052
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00940303     History of Changes
Other Study ID Numbers: ML20514
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action