S0025 Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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|ClinicalTrials.gov Identifier: NCT00053833|
Recruitment Status : Terminated (lack of accrual)
First Posted : February 6, 2003
Last Update Posted : November 8, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: irinotecan||Phase 2|
- Determine the objective confirmed and unconfirmed complete and partial response rates of patients with platinum- and taxane-refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with irinotecan.
- Determine the progression-free and overall survival of patients treated with this drug.
- Evaluate the qualitative and quantitative toxic effects of this drug in these patients.
OUTLINE: Patients receive irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||S0025: Phase II Trial Of Irinotecan (CAMPTOSAR) For Patients With Platinum And Taxane Refractory Ovarian, Peritoneal Or Fallopian Tube Cancer|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||July 2004|
|Actual Study Completion Date :||July 2004|
Other Name: camptosar
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053833
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|Study Chair:||Amy D. Tiersten, MD||New York University School of Medicine|