Phase II study of trastuzumab and paclitaxel in patients with HER2 positive (IHC 3+, IHC 2+ and FISH +) previously treated advanced or recurrent gastric cancer

Phase 2

• Conditions: HER2 positive advanced or recurrent gastric cancer

• Registration Number: JPRN-UMIN000006223
• Lead Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1)Histlogically confirmed Gastric adenocarcinoma
2) Age: 20 years or older
3) HER2 positive (IHC 3+ or IHC 2+ /FISH +)
4)Previous chemotherapy completed at least 14 days before.
5) received one or more prior chemotherapy for gastric carcinoma, does not include trastuzumab and taxanes.
6)History of chemotherapy must be contain 5-fluoropyrimidine
7) Measurable lesion(s) according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline.
8)Performance Status (ECOG scale) 0-2
9)Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram. MUGA scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of >= 50% required)
10) Adequate organ function as follows:
i) neutrophils >=1,500/mm3,
ii) platelets >=100,000/mm3,
iii) hemoglobin >=8.0g/dL,
iv) total bilirubin <=1.5mg/dL,
v) AST(GOT)/ALT(GPT) <=100IU/L,
in hepatic metastasis <=200IU/L,
vi) serum creatinine <2.0mg/dL or creatinine clearance >=30mL/min.
11)Written informed consent.

Exclusion Criteria

1) Active synchronous or metachronous malignancy carcinoma in situ.
2) Severe or uncontrolled medical conditions (e.g.; infection, pulmonary fibrosis, intestinal paralysis, ileus, uncontrolled diabetes mellitus, cirrhosis, myocardial infarction and unstable angina.)
3) Severe infection and inflammation.
4) Severe mental disorders.
5) Peripheral motor or sensory neuropathy of CTCAEver.4.0 Grade2 or more.
6) Cardiac effusion, pleural or peritoneal effusion requiring treatment.
7) Polyoxyethylene Castor Oil allergy.
8) Administration of disulfiram,cyanamide,carmofur and procarbazine hydrochloride.
9)Pregnant or lactating female at anytime during the study
10) Other patients who are not suitable t for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best Overall Response Rate

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival<br>Time to Treatment Failure<br>Overall Survival<br>Adverse events