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

NCT ID: NCT00940303

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

5-FU

Intervention Type DRUG

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

bevacizumab [Avastin]

Intervention Type DRUG

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

irinotecan

Intervention Type DRUG

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

leucovorin

Intervention Type DRUG

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

oxaliplatin

Intervention Type DRUG

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

Interventions

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5-FU

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

Intervention Type DRUG

bevacizumab [Avastin]

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

Intervention Type DRUG

irinotecan

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

Intervention Type DRUG

leucovorin

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

Intervention Type DRUG

oxaliplatin

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Berlin, , Germany

Site Status

Berlin, , Germany

Site Status

Bochum, , Germany

Site Status

Celle, , Germany

Site Status

Celle, , Germany

Site Status

Dessau, , Germany

Site Status

Freiburg im Breisgau, , Germany

Site Status

Fulda, , Germany

Site Status

Hamburg, , Germany

Site Status

Hamburg, , Germany

Site Status

Hanover, , Germany

Site Status

Leer, , Germany

Site Status

Magdeburg, , Germany

Site Status

Magdeburg, , Germany

Site Status

Nuremberg, , Germany

Site Status

Stade, , Germany

Site Status

Villingen-Schwenningen, , Germany

Site Status

Countries

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Germany

References

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Stein A, Atanackovic D, Hildebrandt B, Stubs P, Brugger W, Hapke G, Steffens CC, Illerhaus G, Bluemner E, Stohlmacher J, Bokemeyer C. Upfront FOLFOXIRI+bevacizumab followed by fluoropyrimidin and bevacizumab maintenance in patients with molecularly unselected metastatic colorectal cancer. Br J Cancer. 2015 Sep 15;113(6):872-7. doi: 10.1038/bjc.2015.299. Epub 2015 Sep 3.

Reference Type DERIVED
PMID: 26335608 (View on PubMed)

Other Identifiers

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2008-001180-11

Identifier Type: -

Identifier Source: secondary_id

ML20514

Identifier Type: -

Identifier Source: org_study_id