A Study of Xeloda (Capecitabine) as a First-Line Therapy in Patients With Metastatic Colorectal Cancer - Full Text View

Purpose

This 4 arm study will assess the efficacy and safety of oral Xeloda, or intravenous (iv) fluorouracil/leucovorin, in combination with iv Eloxatin (oxaliplatin) with or without iv Avastin as a first-line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin), in 3 week cycles, 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles), 3) XELOX + Avastin (7.5 mg iv on day 1)in 3 week cycles or 4)FOLFOX-4 + Avastin (5mg iv on day 1)in 2 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Colorectal Cancer	Drug: capecitabine [Xeloda] Drug: Oxaliplatin Drug: Leucovorin Drug: 5 FU Drug: Avastin	Phase III

MedlinePlus related topics:

Cancer Colorectal Cancer

Drug Information available for:

Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Capecitabine Bevacizumab Fluorouracil Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Open-Label Study Comparing the Effect of First-Line Treatment With Intermittent Xeloda Versus Fluorouracil/Leucovorin, Both in Combination With Eloxatin With or Without Avastin, on Tumor Progression in Patients With Metastatic Colorectal Cancer

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Non-inferiority of XELOX vs FOLFOX, with respect to time to progression or death, and superiority of Avastin vs placebo. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival, overall response rate, time to response, duration of response, time to treatment failure. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs, laboratory tests. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	1920
Study Start Date:	July 2003
Estimated Study Completion Date:	May 2009

Arms	Assigned Interventions
1: Experimental	Drug: capecitabine [Xeloda] 1000mg/m2 po bid on days 1-15 of each 3 week cycle.
2: Active Comparator	Drug: Oxaliplatin As prescribed in 2 week cycles. Drug: Leucovorin As prescribed, in 2 week cycles Drug: 5 FU As prescribed, in 2 week cycles.
3: Active Comparator	Drug: capecitabine [Xeloda] 1000mg/m2 po bid on days 1-15 of each 3 week cycle. Drug: Oxaliplatin As prescribed in 3 week cycles Drug: Avastin 7.5mg iv on day 1 in each 3 week cycle
4: Active Comparator	Drug: Leucovorin As prescribed, in 2 week cycles Drug: 5 FU As prescribed, in 2 week cycles. Drug: Avastin 5mg iv on day 1 of each 2 week cycle

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;
metastatic colorectal cancer;
>=1 target lesion.

Exclusion Criteria:

previous treatment with oxaliplatin or bevacizumab;
previous systemic chemotherapy or immunotherapy for advanced or metastatic disease;
progressive disease during or within 6 months of completion of previous adjuvant therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069095

Show 207 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:	NO16966
First Received:	September 15, 2003
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00069095
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Capecitabine

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Disease Progression

Leucovorin

Bevacizumab

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Oxaliplatin

Digestive System Diseases

Fluorouracil

Gastrointestinal Neoplasms

Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites

Vitamin B Complex

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Angiogenesis Inhibitors

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Vitamins

Therapeutic Uses

Growth Inhibitors

Angiogenesis Modulating Agents

Micronutrients

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00069095