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

Conditions

• Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

May 31, 2008

Status verified

Feb 2018

Primary completion

Mar 31, 2009

Completion

Mar 31, 2009

Study Design

Enrollment

41 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: XELOX + bevacizumab (Q2W)
• Experimental: XELIRI + bevacizumab (Q2W)

Primary Outcome Measure

Progression-free Survival (PFS) in U.S. Patients Only [ Time Frame: From first patient enrolled up to approximately 48 months ]

Locations (76)

Find similar trials in PARK Springs, AZ

Related Studies

• Evaluation for NCI Surgery Branch Clinical Research Protocols
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer Patients
  Recruiting · Vanderbilt University Medical Center · Nashville, Tennessee
• ColoCare Study - Colorectal Cancer Cohort
  Recruiting · University of Utah · Los Angeles, California
• Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
  PHASE1/PHASE2 · Recruiting · Lumicell, Inc. · Boston, Massachusetts