Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
|ClinicalTrials.gov Identifier: NCT00003345|
Recruitment Status : Completed
First Posted : March 30, 2004
Last Update Posted : June 21, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: cisplatin Drug: irinotecan hydrochloride||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Official Title:||Phase II Trial of Cisplatin and Irinotecan in Patients With Suboptimally Debulked, Incompletely Responding Ovarian Cancer|
|Study Start Date :||October 1997|
|Actual Primary Completion Date :||October 2001|
|Actual Study Completion Date :||October 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003345
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David R. Spriggs, MD||Memorial Sloan Kettering Cancer Center|