NCT02429687

TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors

A Multicenter, Prospective, Randomized Trial Comparing Paclitaxel and Carboplatin or Bleomycin, Etoposide and Cisplatin in the Treatment of Malignant Ovarian Germ Cell Tumors

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: Beihua Kong · Academic / Other
• Sex: Female
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has the same curative effects and less adverse effects than bleomycin, etoposide and cisplatin(BEP) among newly diagnosed malignant ovarian germ cell tumor patients after surgery.

Detailed description

PRIMARY OBJECTIVES: To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin \[BEP\] as a reference) for newly diagnosed malignant ovarian germ cell tumors. SECONDARY OBJECTIVES: 1. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population. 2. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP. 3. To evaluate response rate in the subset of patients with measurable disease. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. ARM 1: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. ARM 2: Patients receive bleomycin IM daily for days 1-3, etoposide IV daily for days 1-5, cisplatin IV for days 1-5. Treatment repeats every 21 days for 3 or 4\* courses in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses. Patients undergo blood sample collection at baseline and periodically during study for laboratory biomarker analysis. After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

• Ovarian Germ Cell Cancer
• Ovarian Neoplasms
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	Patients receive paclitaxel 175mg/㎡ IV over 3 hours on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
DRUG	Carboplatin	and carboplatin AUC 5-6 IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
DRUG	Bleomycin	Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.
DRUG	Etoposide	Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.
DRUG	Cisplatin	Cisplatin 20mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity.

Timeline

• Start date: 2015-04-01
• Primary completion: 2025-05-01
• Completion: 2030-05-01
• First posted: 2015-04-29
• Last updated: 2023-04-25

Locations

1 site across 1 country: China