Roche trials database

Trial information

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

Status:

Active, not recruiting

Protocol number:

ML20514

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific 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)

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. Target sample size is 97.

Study phase:

II

Study type:

Interventional; Treatment; Non-randomized; Open label; Uncontrolled; Single group; Safety/efficacy study

Conditions:

• Colorectal Cancer

Primary outcome:

1. Progression-free survival Time frame: assessed every 8 weeks up to week 102, 3-monthly during follow-up

Key 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

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.

Gender:

Males or Females

Age limits:

Min: 18 years Max: 70 years

Accepts healthy volunteers:

No

Anticipated start date:

June, 2009

Trial registration date:

02.09.2008

Date last updated:

10.06.2013

This trial was conducted at the following locations:

Germany

• BERLIN
• BOCHUM
• HAMBURG
• HANNOVER
• LEER
• MAGDEBURG
• VILLINGEN-SCHWENNINGEN

GERMANY

• Berlin
• Celle
• Dessau-Roßlau
• Freiburg
• Fulda
• HAMBURG
• Magdeburg
• Nürnberg
• STADE

Link to trial result