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A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.

Primary Purpose

Colorectal Cancer

Status

Withdrawn

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

bevacizumab [Avastin]

Irinotecan

Leucovorin

5 FU

Cetuximab

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

adult patients, >=18 years of age;
colorectal cancer;
advanced or recurrent disease;
>=1 measurable lesion;
>=6 months since prior adjuvant therapy, and >=4 weeks since prior radiotherapy.

Exclusion Criteria:

previous treatment for colorectal cancer;
significant history of cardiac disease in past 6 months;
other invasive malignancy within past 5 years, except for nonmelanoma skin cancer, and successfully treated cervical or prostate 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

Objective response rate, rate of resection of hepatic metastases, overall survival.

AEs, laboratory parameters.

Full Information

NCT ID

NCT00577109

First Posted

December 18, 2007

Last Updated

July 27, 2018

Sponsor

Hoffmann-La Roche

Collaborators

Merck KGaA, Darmstadt, Germany

1. Study Identification

Unique Protocol Identification Number

NCT00577109

Brief Title

A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.

Official Title

An Open Label Study to Assess the Effect of FOLFIRI Plus Avastin and Cetuximab on Progression-free Survival in Patients With Previously Untreated Metastatic Colorectal Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Study was cancelled before patient enrollment

Study Start Date

December 2007 (Anticipated)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

Collaborators

Merck KGaA, Darmstadt, Germany

4. Oversight

5. Study Description

Brief Summary

This single arm study will assess the efficacy and safety of a combination of modified FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan 180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of 400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity, 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

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

bevacizumab [Avastin]

Intervention Description

5mg/kg iv on day 1 of each 2 week cycle

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Intervention Description

180mg/m2 iv on day 1 of each 2 week cycle

Intervention Type

Drug

Intervention Name(s)

Leucovorin

Intervention Description

200mg/m2 iv on day 1 of each 2 week cycle

Intervention Type

Drug

Intervention Name(s)

5 FU

Intervention Description

400mg/m2 iv on day 1 of each 2 week cycle

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Intervention Description

Loading dose of 400mg/m2 iv followed by 250mg/m2 iv on day 3 of each 2 week cycle

Primary Outcome Measure Information:

Title

Progression-free survival

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Objective response rate, rate of resection of hepatic metastases, overall survival.

Time Frame

Event driven

Title

AEs, laboratory parameters.

Time Frame

Throughout study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: adult patients, >=18 years of age; colorectal cancer; advanced or recurrent disease; >=1 measurable lesion; >=6 months since prior adjuvant therapy, and >=4 weeks since prior radiotherapy. Exclusion Criteria: previous treatment for colorectal cancer; significant history of cardiac disease in past 6 months; other invasive malignancy within past 5 years, except for nonmelanoma skin cancer, and successfully treated cervical or prostate 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

Salvador

Country

Brazil

City

Sao Paulo

Country

Brazil

City

Sorocaba

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.

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