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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00623805
First received: February 18, 2008
Last updated: October 7, 2013
Last verified: October 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 123
Study Start Date: March 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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
Experimental: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Turkey
Ankara, Turkey, 06100
Ankara, Turkey, 06590
Ankara, Turkey, 06500
Gaziantep, Turkey, 27310
Istanbul, Turkey, 34300
Istanbul, Turkey, 34890
Istanbul, Turkey, 34390
Izmir, Turkey, 35100
Izmir, Turkey, 35340
S?hhiye, ANKARA, Turkey, 06100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00623805     History of Changes
Other Study ID Numbers: ML21440
Study First Received: February 18, 2008
Last Updated: October 7, 2013
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Capecitabine
Bevacizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014