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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00940303
First received: July 6, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Colorectal Cancer
 Drug: bevacizumab [Avastin]
Drug: oxaliplatin
Drug: irinotecan
Drug: leucovorin
Drug: 5-FU
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: assessed every 8 weeks up to week 102, 3-monthly during follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: June 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
5mg/kg iv infusion, day 1 every 2 weeks
Drug: oxaliplatin
85mg/m2 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: 5-FU
3200mg/m2 continuous iv infusions, day 1 every 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940303

Locations
Germany
Berlin, Germany, 13353
Berlin, Germany, 13347
Bochum, Germany, 44791
Celle, Germany, 29223
Celle, Germany, 29221
Dessau, Germany, 06822
Freiburg, Germany, 79106
Fulda, Germany, 36043
Hamburg, Germany, 22087
Hamburg, Germany, 20251
Hannover, Germany, 30171
Leer, Germany, 26789
Magdeburg, Germany, 39130
Magdeburg, Germany, 39120
Nürnberg, Germany, 90419
Stade, Germany, 21680
Villingen-schwenningen, Germany, 78045
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00940303     History of Changes
Other Study ID Numbers: ML20514, 2008-001180-11
Study First Received: July 6, 2009
Last Updated: May 7, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Bevacizumab
Levoleucovorin
Oxaliplatin
 Irinotecan
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013