A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

Hoffmann-La Roche52 enrolled

Overview

This study will assess the efficacy and safety of intermittent oral Xeloda administration in combination with irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

IrinotecanDRUG

250mg/m2 iv on day 1 of each 3 week cycle

capecitabine [Xeloda]DRUG

1000mg/m2 po bid on days 1-15 of each 3 week cycle

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients \>=18 years of age; * locally advanced and/or metastatic colorectal cancer; * \>=1 target lesion. Exclusion Criteria: * previous treatment with Xeloda or irinotecan; * previous systemic therapy for metastatic disease; * progressive disease during previous adjuvant therapy or within 6 months of completion.

Locations (11)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Fountain Valley, California, United States

Unnamed facility

La Jolla, California, United States

Unnamed facility

Santa Rosa, California, United States

Outcomes

Primary Outcomes

Tumor measurement (RECIST criteria)

Time frame: Event driven

Secondary Outcomes

Efficacy: Time to progression, time to response, duration of response, time to treatment failure, survival.

Time frame: Event driven

Data from ClinicalTrials.gov

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