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

Colorectal Cancer Clinical Trial

Official title:

A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700102
• Other study ID #: ML18147
• Secondary ID: 2006-004634-32
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2008
• Last updated: July 2, 2015
• Start date: February 2006
• Est. completion date: May 2013

Study information

• Verified date: July 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 820
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Chemotherapy
As prescribed
• Bevacizumab
Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Denmark,  Estonia,  Finland,  France,  Germany,  Netherlands,  Norway,  Portugal,  Saudi Arabia,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival: Time From Randomization to Death From Any Cause		within 6.5 years	No
Secondary	Overall Survival: Months From Time of First Line Therapy		within approximately 9.6 years	No
Secondary	Participants With Progression Free Survival Event		within 6.5 years	No
Secondary	Progression Free Survival: Time to Event		within 6.5 years	No
Secondary	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	No
Secondary	Response Rate: Participants With Response Status Based on RECIST Criteria	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.	within 6.5 years	No