A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Chemotherapy; Drug: Bevacizumab

• Registration Number: NCT00700102
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-07
• Results First Submitted: 2015-07-02
• Results First Submitted QC: 2015-07-02
• Last Update Submitted: 2015-07-02
• Results First Posted: 2015-07-30
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 820

Inclusion Criteria

• Adult patients, >=18 years of age
• Metastatic colorectal cancer and disease progression
• Previously treated with first-line chemotherapy plus Avastin
• Eastern Cooperative Oncology Group (ECOG) performance status <=2.

Exclusion Criteria

• Diagnosis of progression of disease more than 3 months after last Avastin administration
• First-line patients with progression-free survival in first-line of <3 months
• Patients receiving less than 3 consecutive months of Avastin in first-line therapy
• Past or current history (within the last 2 years prior to treatment start) of other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix
• Clinically significant cardiovascular disease within 6 months prior to start of study treatment
• Known central nervous system (CNS) disease, except for treated CNS metastases as defined by protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Chemotherapy	Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
Chemotherapy + Bevacizumab	Chemotherapy	Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
Chemotherapy + Bevacizumab	Bevacizumab	Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal

Primary Outcome Measures

Name	Time	Method
Overall Survival: Time From Randomization to Death From Any Cause	within 6.5 years

Secondary Outcome Measures

Name	Time	Method
Participants With Progression Free Survival Event	within 6.5 years
Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria	within 6.5 years
Response Rate: Participants With Response Status Based on RECIST Criteria	within 6.5 years	Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
Overall Survival: Months From Time of First Line Therapy	within approximately 9.6 years
Progression Free Survival: Time to Event	within 6.5 years