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NCT Number: NCT00940303

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5-FU

Drug

3200mg/m2 continuous iv infusions, day 1 every 2 weeks

bevacizumab [Avastin]

Drug

5mg/kg iv infusion, day 1 every 2 weeks

Irinotecan

Drug

165mg/m2 iv infusion, day 1 every 2 weeks

Leucovorin

Drug

200mg/m2 iv infusion, day 1 every 2 weeks

Oxaliplatin

Drug

85mg/m2 iv infusion, day 1 every 2 weeks

Primary outcomes

  1. Progression-free survival

    Time frame: assessed every 8 weeks up to week 102, 3-monthly during follow-up

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jul 16, 2009
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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