NCT00006028

Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy

Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.

Detailed description

OBJECTIVES: * Determine the anti-tumor activity of gemcitabine and cisplatin in patients with recurrent or refractory platinum-resistant ovarian epithelial cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols. * Determine the nature and degree of toxicity of this regimen in this patient population. * Correlate ex vivo drug sensitivity and resistance with clinical response to this regimen in these patients. * Correlate molecular markers of drug responsiveness and cellular apoptosis with ex vivo measures of drug resistance in these patients. OUTLINE: This is a multicenter study. Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1 and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14 months.

Conditions

• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 2001-01-01
• Primary completion: 2007-01-01
• First posted: 2003-01-27
• Last updated: 2013-05-27

Locations

31 sites across 2 countries: United States, Norway