Intergroup trial: Randomized Phase II Clinical Trial of Pegylated Liposomal Doxorubicin plus Carboplatin versus Gemcitabine plus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian Carcinoma, Primary Carcinoma of FallopianTube, and Peritoneal Carcinoma after Failure of Initial Platinum-based Chemotherapy
- Conditions
- Platinum-Sensitive Patients with Recurrent Epithelial Ovarian Carcinoma, Primary Carcinoma of FallopianTube, and Peritoneal Carcinoma
- Registration Number
- JPRN-UMIN000005487
- Lead Sponsor
- Gynecologic Oncology Trial and Investigation Consortium
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 100
Not provided
1)Patients with fever of over 38.0 degrees C 2)Patients with active infection 3)Patients with serious complications 4)Patients with a second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) 5)Patients with prior radiation therapy 6)Patients with pleural effusion,ascites or pericardial effusion which requires persistent drainage 7)Patients with prior treatment of Anthracycline or Gemcitabine Hydrochloride 8)Patients with clinical symptom of brain metastasis requiring medication 9)Patients with hepatic damage (hepatitis,hepatic cirrhosis), history or evidence upon alcoholism 10)Patients with positive HBsAg. 11)Patients with a history of hypersensitivity to Doxorubicin 12)Patients who are pregnant or nursing or of child bearing potential 13)Patients judged inappropriate for this study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Overall response rate Overall survival Adverse event Tolerability