A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00642577

Purpose

This 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 100-500 individuals.

Condition	Intervention	Phase
Colorectal Cancer	Drug: bevacizumab [Avastin] Drug: irinotecan Drug: leucovorin Drug: fluorouracil	Phase III

MedlinePlus related topics: Cancer Colorectal Cancer

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

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 to Compare the Effect of First-Line Treatment With Avastin in Combination With Irinotecan + 5-Fluorouracil/Folinic Acid, and Irinotecan + 5-Fluorouracil/Folinic Acid Alone, on Progression-Free Survival in Chinese Patients With Metastatic Colorectal Cancer.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Progression-free survival. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	210
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 5mg/kg iv every 2 weeks Drug: irinotecan 125mg/m2 iv weekly for 4 weeks of each 6 week cycle Drug: leucovorin 20mg/m2 iv weekly for 4 weeks of each 6 week cycle Drug: fluorouracil 500mg/m2 iv weekly for 4 weeks of each 6 week cycle
2: Active Comparator	Drug: irinotecan 125mg/m2 iv weekly for 4 weeks of each 6 week cycle Drug: leucovorin 20mg/m2 iv weekly for 4 weeks of each 6 week cycle Drug: fluorouracil 500mg/m2 iv weekly for 4 weeks of each 6 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;
histologically confirmed adenocarcinoma of the colon or rectum, with metastatic disease;
>=1 measurable lesion;
ECOG performance status of <=1.

Exclusion Criteria:

prior systemic therapy for advanced or metastatic disease;
adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
other malignancy within past 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
clinically significant cardiovascular disease in past 6 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642577

Locations

China

GUANGZHOU, China, 510060

GUANGDONG, China, 510515

WUHAN, China, 430030

BEIJING, China, 100036

BEIJING, China, 100021

BEIJING, China, 100071

NANJING, China, 210002

SHANGHAI, China, 200080

TIANJIN, China, 300060

CHONGQING, China, 400042

QINGDAO, China, 266003

SHANGHAI, China, 200003

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:	BO20696
Study First Received:	March 19, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00642577
Health Authority:	China: Ministry of Health

Study placed in the following topic categories:

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

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

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors

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

ClinicalTrials.gov processed this record on January 16, 2009