A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer

Roche

Status and phase

Terminated

Phase 4

Conditions

Gastric Cancer

Treatments

Drug: trastuzumab [Herceptin]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01260194

ML25477

Details and patient eligibility

About

This open-label, multi-center study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction. Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients, >/=18 years of age
Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with advanced or metastatic disease, not amenable to curative therapy
Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
HER2 positive tumor (primary tumor or metastasis
ECOG Performance status 0, 1 or 2
Life expectancy of at least 3 months

Exclusion criteria

Previous chemotherapy for advanced or metastatic disease less than 6 month before study start
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (patients with partial or total gastrectomy are allowed to participate in the study)
Patients with active (significant or uncontrolled) gastrointestinal bleeding
Residual relevant toxicity resulting from previous chemotherapy
Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or basal cell carcinoma)