A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00623805

Purpose

This 2 arm study will assess the efficacy and safety of maintenance treatment with Avastin + Xeloda, after initial treatment with Xeloda + oxaliplatin + Avastin, in patients with metastatic colorectal cancer. Patients will be randomized into one of 2 groups to receive 1)Xeloda + oxaliplatin + Avastin until disease progression or 2)Xeloda + oxaliplatin + Avastin for 6 x 3 week cycles, followed by Xeloda + Avastin until disease progression. Xeloda will be administered at a dose of 1000mg/m2 po bid on days 1-14 of each cycle, oxaliplatin at a dose of 130mg/m2 iv on day 1 of each cycle, and Avastin at a dose of 7.5mg/kg iv on day 1 of each cycle. 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: bevacizumab [Avastin] Drug: Oxaliplatin Drug: capecitabine [Xeloda]	Phase III

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: 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 to Assess the Effect on Progression-Free Survival and Disease Response of Avastin + Xeloda as Maintenance Treatment, After Initial Combination Treatment With Xeloda + Oxaliplatin + Avastin in Patients With Metastatic Colorectal Adenocarcinoma

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival, overall response rate, time to response, duration of response, surgery with curative intent. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	118
Study Start Date:	March 2008
Estimated Study Completion Date:	November 2010

Arms	Assigned Interventions
1: Active Comparator	Drug: bevacizumab [Avastin] 7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression Drug: Oxaliplatin 130mg/m2 iv on day 1 of each 3 week cycle for 6 cycles only on day 1 of each 3 week cycle for a total of 6 cycles Drug: capecitabine [Xeloda] 1000mg/m2 po on day 1 of each 3 week cycle until disease progression
2: Experimental	Drug: bevacizumab [Avastin] 7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression Drug: Oxaliplatin 130mg/m2 iv on day 1 of each 3 week cycle until disease progression. Drug: capecitabine [Xeloda] 1000mg/m2 po on day 1 of each 3 week cycle until disease progression

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 colon or rectal cancer, with unresectable metastatic disease;
at least one measurable lesion;
outpatient, with ECOG Performance Status 0-1.

Exclusion Criteria:

previous treatment with Avastin;
previous systemic treatment for advanced or metastatic disease;
clinically significant cardiovascular disease;
daily chronic treatment with high doses of aspirin (>325mg/day) or NSAIDs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623805

Contacts

Contact: Please reference Study ID Number: ML21440	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Turkey
	Recruiting
ANKARA, Turkey, 06100
	Recruiting
ANKARA, Turkey, 06500
	Recruiting
ANKARA, Turkey, 6100
	Recruiting
ISTANBUL, Turkey, 34662
	Recruiting
IZMIR, Turkey, 35100
	Recruiting
ISTANBUL, Turkey, 34390
	Recruiting
ANKARA, Turkey, 06590
	Recruiting
ISTANBUL, Turkey, 34300
	Recruiting
GAZIANTEP, Turkey, 27310
	Recruiting
IZMIR, Turkey, 35340

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:	ML21440
Study First Received:	February 18, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00623805
Health Authority:	Turkey: Ministry of Health

Study placed in the following topic categories:

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

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

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on January 16, 2009