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

An Open-label Study of the Effect of Intermittent Xeloda in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00048139

Enrollment

Registered

2002-10-25

Start date

2001-10-31

Completion date

2005-06-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

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.

Interventions

DRUGIrinotecan

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

DRUGcapecitabine [Xeloda]

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Tumor measurement (RECIST criteria)	Event driven

Secondary

Measure	Time frame
Efficacy: Time to progression, time to response, duration of response, time to treatment failure, survival.	Event driven

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026