Phase II study of Weekly Paclitaxel+Weekly Carboplatin for Platinum/Taxan sensitive recurrent mullerian carcinoma

Phase II study of Weekly Paclitaxel+Weekly Carboplatin for Platinum/Taxan sensitive recurrent mullerian carcinoma - Phase II study of Platinum/Taxan sensitive recurrent mullerian carcinoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003476

Enrollment

Registered

2010-04-12

Start date

2009-10-01

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

Platinum/Taxan sensitive recurrent mullerian carcinoma

Interventions

Paclitaxel 80mg/m2 day1,8,15+Carboplatin AUC=2 day1,8,15 q 4weeks 6cycle

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Histology or cytologically confirmed ovarian epithelial,primary peritoneal cabity,or fallopian tube cancer. 2.Failed prior primary pratinum-based therapy.(Progression-free interval>=6months) 3.Measurable lesion by CTscan,MRI 4.Age 20-75 5.ECOG performance status(PS)0-2 6.Patient characteristics Inclusion criteria: 6-1.ANC1,500/mm3 6-2.Platelet count>=100,000/mm3 6-3.ALT and AST=<2.5xULN 6-4.Serum bilirubin=<1.5mg/dL 6-5.Creatinine=<1.5mg/dL 7.Patient provided written informed concent befor initiation of study-related procedures.

Exclusion criteria

Exclusion criteria: 1.Progression free interval<6months 2.Prior chemotherapy>2regimen 3.Pleural effusion need to continued drainage. 4.Evidense of severe or uncontrolled cardiac disease. 5.Hystory of myocardial infarction within 6months. 6.Hystory of cirrhosis or active hepatitis. 7.Severe plumonary disease(interstitial pneumonia,pulmonary fibrosis,)8.Gastrointestinal bleeding that requires iteration transfusion. 9.Serius psychological disease. 10.Uncontrolled diabetes. 11.Bowel obstruction. 12.Infection with fever. 13.Active double carcinoma. 14.Symptomatic brain metastasis. 15.Accute inflammatory desease. 16.Sevre peripheral neuropathy. 17.Patients with any history of serious drug reactions 18.History of hyper sensitivity to polyoxyethylene castor oil(ChremophorEL) or contained castor oil(vitamin injection) 19.Pregnant or lactating woman. 20.Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
(1)Overall survival (2)Progression free survival (3)Incidence of morbidity	—

Countries

Japan

Contacts

Public ContactKyosuke Yamada

Jikei University Hospital Department of Obstetrics and Gynecology

Outcome results

None listed

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