Randomized phase II study comparing trastuzumab plus weekly paclitaxel with weekly paclitaxel alone for patients with HER2-positive advanced gastric or gastro-esophageal junction cancer refractory to trastuzumab combined with fluoropyrimidine and platinum.

Randomized phase II study comparing trastuzumab plus weekly paclitaxel with weekly paclitaxel alone for patients with HER2-positive advanced gastric or gastro-esophageal junction cancer refractory to trastuzumab combined with fluoropyrimidine and platinum. - Trial to Assess the Concept of using Trastuzumab beyond progression

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009297

Enrollment

Registered

2012-11-09

Start date

2012-12-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric or gastro-esophageal junction adenocarcinoma

Interventions

weekly paclitaxel trastuzumab + weekly paclitaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven advanced unresectable or recurrent gastric or gastro-esophageal junction adenocarcinoma 2) Her2 positive (IHC3+ or ICH2+/FISH >=2.0) 3) Measurable or evaluable lesion 4) No previous chemotherapy nor radiation therapy for malignant tumor except for gastric cancer. 5) Refractory to fluoropyrimidine , platinum and trastuzumab containing chemotherapy. 6) Prior trastuzumab therapy with more than three doses, and within 6 weeks from last trastuzumab administration. 7) No prior therapy with taxan. 8) No prior therapy with anti-HER2 drugs except trastuzumab 9) No ileus or sub-ileus 10) ECOG performance status 0-2. 11) Expected survival >= 90 days. 12) Adequate bone marrow and organ function as defined as below: leukocyte count >=3000/mm3 neutrophil count >=1500/mm3 hemoglobin level >= 8.0 g/dL platelet count >= 100,000/mm3 AST and ALT <= 100 IU/L, or AST and ALT <=200 IU/L with liver metastases total bilirubin <= 1.5 mg/dL serum creatinine <=2.0 mg/dL 13) Left Ventricular Ejection Fraction (LVEF) >=50% measured by echocardiography or multi-gated acquisition scan (MUGA) 14) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Discontinuation of trastuzumab due to adverse event. 2) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma. 3) Evidence of any other serious disease, e.g. active gastrointestinal hemorrhage, uncontrolled cardiovascular disease and uncontrolled diabetes mellitus. 4) Active infection under treatment. 5) History of serious allergic reactions. 6) Pulmonary fibrosis or interstitial pneumonitis detected by chest x-ray. 7) Symptomatic brain metastases or carcinomatous meningitis. 8) Massive pericardial effusion, pleural effusion or ascites*. *except for patients if effusions and ascites did no accumulate for more than two weeks after dranage therapy. *include patients if pleurosclerosis was performed with anti-cancer drugs except OK-432. 9) Peripheral sensory neuropathy of grade >= 2 according to NCI-CTCAE version 4.0. 10) Current treatment with corticosteroids. 11) Blood tests positive for HBs antigen. 12) Active gastrointestinal hemorrhage requiring multiple blood transfusions. 13) Uncontrolled psychiatry disease. 14) Pregnant or lactating female. 15) Judged inappropriate by the investigators.

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Overall survival, time to treatment failure, overall response rate, disease control rate, safety and translational biomarker research	—

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026