NCT00003345

Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer

Phase II Trial of Cisplatin and Irinotecan in Patients With Suboptimally Debulked, Incompletely Responding Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• 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 combining cisplatin and irinotecan in treating patients who have ovarian, fallopian tube, or peritoneal cancer.

Detailed description

OBJECTIVES: I. Evaluate the antitumor effect of weekly cisplatin and irinotecan in patients with suboptimally debulked ovarian, fallopian tube, or peritoneal cancer and persistently elevated serum values of CA125 after 3 courses of standard therapy with paclitaxel and either carboplatin or cisplatin. II. Evaluate the toxicity, both qualitative and quantitative, of this regimen in this patient population. III. Evaluate the quality of life of these patients. OUTLINE: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 90 minutes. Treatment is administered weekly for 4 weeks (days 1, 8, 15, and 22) followed by 2 weeks of rest. Patients receive at least 3 courses (18 weeks) of therapy in the absence of disease progression or unacceptable toxicity. If patients demonstrate complete response to treatment, they are encouraged to undergo second-look laparoscopy or laparotomy. Quality of life is assessed before treatment, after the first course, and then after every 2 courses of therapy. Patients are followed 30 days after the last treatment and then for survival. PROJECTED ACCRUAL: There will be 12-35 patients accrued into this study over 18-24 months.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	irinotecan hydrochloride

Timeline

• Start date: 1997-10-01
• Primary completion: 2001-10-01
• Completion: 2001-10-01
• First posted: 2004-03-30
• Last updated: 2013-06-21

Locations

1 site across 1 country: United States