A pilot study of trastuzumab monotherapy in patients who progressed under a previous platinum-based or 5-fluoropyrimidin-based chemotherapy in metastatic or locally advanced gastric cancer

• Conditions: Metastatic or locally advanced gastric cancer (stage IV) with HER2 overexpression; MedDRA version: 7.1Level: PTClassification code 10017767

• Registration Number: EUCTR2005-001220-37-AT
• Lead Sponsor: Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-21
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Age > 18 years (ethnical group: any; gender: female and male)
Progression under or after one prior platinum-based or 5-fluoropyrimidine-based chemotherapy in metastatic disease
At least four weeks from the last platinum-based or 5-fluoropyrimidin-based chemotherapy
Histological proof of gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction with HER2 overexpression of the primary or metastatic tumor tissue determined by immunohistochemistry and FISH (Score IHC 3+ or Score IHC 2+ and FISH +)

Metastatic (M1) or locally advanced disease
At least one measurable lesion evaluable for response (RECIST criteria)
Estimated life expectancy of > 3 months
ECOG Performance Status: 0-2
Adequate cardiac function: LVEF > 50% (detected by echocardiogram)
Absolute neutrophil count > 1,500/µl
Absolute platelet count > 100,000 /µl
Serum total bilirubin: < 2.0 x upper normal limit (UNL)
Creatinine < 1.5 x UNL
AST and ALT < 2.5 x UNL; < 5 x UNL in patients with documented liver metastases
Alkaline phosphatase: < 2.5 UNL
Negative pregnancy test
Willingness to give written informed consent, written consent for data protection and willingness to participate and comply with the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age > 75 years
Concurrent therapy with any other chemo-/immunotherapeutical regime
Clinically significant cardiac disease (cardiac insufficiency, NYHA III/IV, uncontrolled arrhythmia or hypertension, symptomatic angina pectoris, clinically significant valvular heart disease, history of congestive heart failure)
LVEF < 50%
Pregnant or lactating women
Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
Known hypersensitivity reactions to the compounds
Patients with active or uncontrolled infections/concurrent illness
Patients with advanced pulmonary disease, severe dyspnoe or requiring oxygen therapy
Patients with brain or meningeal metastases. Radiologic studies are not required to rule this out unless there is clinical suspicion of CNS disease
Other co-exisiting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma of cervical cancer in situ. Patients curatively treated and free of disease for at least 5 years will be discussed with the sponsor before inclusion.
Concomitant or within a 4-week period administration of any other experimental drug under investigation.
Alcohol and/or drug abuse
Patients who cannot be regularly observed for psychological, sociological, geographical reasons or other concomitant conditions not permitting adequate follow-up and compliance of the protocol
patient was already recruited in this trial before

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to determine the response rate (CR + PR) according to RECIST criteria;Secondary Objective: to determine clinical benefit rate (CR + PR + SD) according to RECIST criteria<br>- to determine Time to Progression<br>- to determine Duration of Response<br>- to determine survival<br>- to evaluate the safety of trastuzumab monotherapy in patients with metastatic or locally advanced gastric cancer<br>;Primary end point(s): response rate