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

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

5-FU

bevacizumab [Avastin]

irinotecan

leucovorin

oxaliplatin

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival

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.

Proportion of patients with NCI-CTC grade 3-5 adverse events; adverse events, laboratory parameters, ECOG performance status.

Full Information

NCT ID

NCT00940303

First Posted

July 6, 2009

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00940303

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

5-FU

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

bevacizumab [Avastin]

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

irinotecan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

leucovorin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival

Time Frame

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

Secondary Outcome Measure Information:

Title

Time Frame

assessed every 4 weeks up to week 102 and at the end of follow-up period

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Berlin

ZIP/Postal Code

10117

Country

Germany

City

Berlin

ZIP/Postal Code

13347

Country

Germany

City

Bochum

ZIP/Postal Code

44791

Country

Germany

City

Celle

ZIP/Postal Code

29221

Country

Germany

City

Celle

ZIP/Postal Code

29223

Country

Germany

City

Dessau-Roßlau

ZIP/Postal Code

06847

Country

Germany

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

City

Fulda

ZIP/Postal Code

36043

Country

Germany

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

City

Hamburg

ZIP/Postal Code

22087

Country

Germany

City

Hannover

ZIP/Postal Code

30171

Country

Germany

City

Leer

ZIP/Postal Code

26789

Country

Germany

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

City

Magdeburg

ZIP/Postal Code

39130

Country

Germany

City

Nürnberg

ZIP/Postal Code

90419

Country

Germany

City

Stade

ZIP/Postal Code

21680

Country

Germany

City

Villingen-Schwenningen

ZIP/Postal Code

78052

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

26335608

Citation

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.

Results Reference

derived

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

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