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

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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Oxaliplatin Capecitabine Bevacizumab Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

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:	2035
Study Start Date:	July 2003
Estimated Study Completion Date:	December 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 236 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NO16966
Study First Received:	September 15, 2003
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00069095 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Vitamin B Complex
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Disease Progression
Leucovorin
Trace Elements
Bevacizumab
Folinic Acid

Intestinal Diseases
Angiogenesis Inhibitors
Rectal Diseases
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Vitamins
Fluorouracil
Gastrointestinal Neoplasms
Micronutrients
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Leucovorin
Bevacizumab
Rectal Diseases
Oxaliplatin
Neoplasms by Site
Vitamins
Therapeutic Uses
Growth Inhibitors

Angiogenesis Modulating Agents
Micronutrients
Capecitabine
Digestive System Neoplasms
Vitamin B Complex
Growth Substances
Intestinal Diseases
Angiogenesis Inhibitors
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009