Trial Information

Summary: ToGA study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

Status: Recruiting

Protocol Number: BO18255

Sponsor: Hoffmann-LaRoche Ltd/Inc/AG/Roche Global Development

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of first-line Herceptin in combination with a fluoropyrimidine and cisplatin versus chemotherapy alone on progression-free survival in patients with HER2-positive advanced gastric cancer

Brief Summary: This study will evaluate the efficacy, safety, pharmacokinetics and effect on quality of life of intravenous Herceptin in combination with 2 different regimens of 2 chemotherapy agents, compared with these chemotherapy regimens alone, in patients with HER2-positive advanced gastric cancer. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 584.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Gastric Cancer

Intervention Type: Drug

Intervention Name: trastuzumab[Herceptin]

Primary Outcome: 1. Efficacy: Overall survival

Key Secondary Outcomes: 1. Efficacy: Progression-free survival, overall response rate, clinical benefit rate, duration of response Safety: AEs, laboratory tests, vital signs, LVEF, creatinine clearance

Inclusion Criteria:

  • adult patients (>=18 years of age);
  • inoperable locally advanced, recurrent, or metastatic cancer of the stomach or gastro-esophageal junction;
  • adenocarcinoma;
  • HER2-positive tumors.

Exclusion Criteria:

  • previous chemotherapy for advanced/metastatic disease;
  • lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome;
  • history of cardiac disease;
  • dyspnoea at rest, due to complications of advanced malignancy or other disease, or patients who require supportive oxygen therapy.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: September, 2005

Trial Registration Date: 08/31/2005

Date Last Updated: 07/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Jiangsu, China, 210002
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 21, 2008 at 2:22:01 PM


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