A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00642603

Purpose

This 2 arm study will 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 will be randomized to receive 2-weekly cycles of treatment with either 1)Xeloda (1000mg/m2 po bid on days 1-7), Avastin (5mg/kg iv on day 1) and oxaliplatin (85mg/m2 on day 1, only in cycles 1-12) or 2)Xeloda (1000mg/m2 po bid on days 1-7), Avastin (5mg/kg iv on day 1) and irinotecan (135mg/m2 on day 1, only in cycles 1-12). After 9 cycles, patients will continue to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Colorectal Cancer	Drug: capecitabine [Xeloda] Drug: bevacizumab [Avastin] Drug: oxaliplatin Drug: irinotecan	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride Capecitabine Bevacizumab Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Progression-free survival (PFS), in patients enrolled in US only [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PFS in all patients, overall response rate, overall survival, time to response, duration of overall response, time to progression, time to treatment failure, rate of completion of 12 cycles of triple-drug therapy, rate of surgical intervention. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
PFS rates [ Time Frame: 6, 9 and 12 months ] [ Designated as safety issue: No ]
Adverse events, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2013

Arms	Assigned Interventions
1: Experimental	Drug: capecitabine [Xeloda] 1000mg/m2 po bid on days 1-7 of each 2 week cycle Drug: bevacizumab [Avastin] 5mg/kg iv on day 1 of each 2 week cycle Drug: oxaliplatin 85mg/m2 on day 1 of each 2 week cycle, for first 9 cycles.
2: Experimental	Drug: capecitabine [Xeloda] 1000mg/m2 po bid on days 1-7 of each 2 week cycle. Drug: bevacizumab [Avastin] 5mg/kg iv on day 1 of each 2 week cycle Drug: irinotecan 135mg/m2 on day 1 of each 2 week cycle, for first 9 cycles.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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 >325mg/day aspirin.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642603

Contacts

Contact: Please reference Study ID Number: ML21567	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 112 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML21567
Study First Received:	March 19, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00642603
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Disease Progression
Bevacizumab

Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009