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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00940303

Enrollment

Registered

2009-07-16

Start date

2009-06-30

Completion date

2014-02-28

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

DRUG5-FU

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

DRUGbevacizumab [Avastin]

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

DRUGirinotecan

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

DRUGleucovorin

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

DRUGoxaliplatin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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.	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.	Throughout study, laboratory analyses every 2 weeks, ECOG assessment every 8 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026