A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Randomized, Open Label Study of the Effect of First Line Treatment With Xeloda in Combination With Avastin and Either Short Course Irinotecan or Short Course Oxaliplatin on Progression-free Survival in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00642603
• Other study ID #: ML21567
• Status: Terminated
• Phase: Phase 2
• First received: March 19, 2008
• Last updated: February 28, 2018
• Start date: May 2008
• Est. completion date: March 2009

Study information

• Verified date: February 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, =18 years of age

• Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease

• =1 measurable target lesion

• Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of =1

Exclusion Criteria:

• Prior systemic therapy for advanced or metastatic disease

• History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix

• Clinically significant cardiovascular disease

• Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents

• Chronic daily treatment with >325 mg/day aspirin

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• capecitabine [Xeloda]
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
• capecitabine [Xeloda]
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
• bevacizumab [Avastin]
5 mg/kg taken intravenously on Day 1 of each 2 week cycle
• oxaliplatin
85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
• irinotecan
135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) in U.S. Patients Only	PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.	From first patient enrolled up to approximately 48 months

External Links

•   Clinical Study Report Synopsis