Trial Information

Summary: A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Cisplatin in Patients With Advanced Gastric Cancer.

Status: Recruiting

Protocol Number: BO20904

Sponsor: Hoffmann-La Roche; Genentech Inc.; Chugai Pharmaceutical Co. ltd

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study comparing the effect of first-line therapy with Avastin or placebo, in combination with Xeloda and cisplatin, on overall survival in patients with advanced gastric cancer.

Brief Summary: This study will compare the efficacy and safety of Xeloda and cisplatin in combination with Avastin or placebo in patients with advanced gastric cancer who have received no prior treatment for advanced or metastatic gastric cancer. Patients will be randomized to receive 3-weekly cycles of Xeloda 1000mg/m2 p.o. b.i.d. plus cisplatin 80mg/m2 in combination with either Avastin 7.5mg/kg i.v. or placebo i.v. After a maximum of 6 cycles of oxaliplatin, patients can continue with Xeloda and Avastin or monotherapy with either drug, depending on the toxicity experienced by the patient. Throughout the study, safety will be monitored by an independent data and safety monitoring board. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals. In the US this study is sponsored/managed by Genentech, under protocol no. AVF4200g. Target sample size is 760.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Gastric Cancer

Intervention Type: Drug

Intervention Name: bevacizumab[Avastin]

Primary Outcome: 1. Overall survival.

Key Secondary Outcomes: 1. Efficacy: Progression-free survival, time to progression, overall response rate, duration of response, disease control rate. Safety: AEs, laboratory parameters.

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • inoperable, locally advanced or metastatic cancer of stomach or gastro-esophageal junction;
  • measurable or non-measurable but evaluable disease;
  • ERCOG PS of 0, 1 or 2.

Exclusion Criteria:

  • previous chemotherapy for locally advanced or metastatic gastric cancer;
  • previous platinum or anti-angiogenic therapy;
  • patients with locally advanced disease who are candidates for curative therapy;
  • radiotherapy within 28 days of randomisation;
  • evidence of CNS metastasis;
  • inadequate organ function;
  • history of bleeding or wound-healing complications.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: September, 2007

Trial Registration Date: 07/19/2007

Date Last Updated: 06/17/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Wichita, KS 67214-3728
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: June 30, 2008 at 3:12:59 PM


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