S0025 Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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S0025: Phase II Trial Of Irinotecan (CAMPTOSAR) For Patients With Platinum And Taxane Refractory Ovarian, Peritoneal Or Fallopian Tube Cancer

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: irinotecan


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or pathologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer No mixed mullerian and borderline ovarian tumors Surgically staged as stage III or IV at initial diagnosis Must meet one of the following criteria for refractory/relapsed disease: Relapsed within 6 months after completing front-line concurrent or sequential platinum (either cisplatin or carboplatin) and taxane (paclitaxel or docetaxel) chemotherapy Had a best response of increasing disease during this front-line regimen Consolidation chemotherapy and reinduction therapy are counted as part of the front-line regimen Unidimensionally measurable disease At least 2 cm by medical photograph (skin or oral lesion), palpation, plain x-ray, CT scan, MRI, or other conventional technique (bone lesions not included) At least 1 cm by spiral CT scan Measurable disease must remain outside of radiotherapy field If the tumor is known to be KIT (CD117) or PDGFR positive, patient must be offered SWOG-S0211 if available PATIENT CHARACTERISTICS: Age Not specified Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular No myocardial infarction within the past 6 months No angina pectoris No uncontrolled congestive heart failure No uncontrolled cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except for the following: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Adequately treated stage I or II cancer from which the patient is currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy No more than 1 prior biological response modifier At least 28 days since prior biological response modifier and recovered Chemotherapy See Disease Characteristics No prior topotecan or other topoisomerase I inhibitor One other additional prior chemotherapy regimen allowed At least 28 days since prior chemotherapy (14 days for weekly chemotherapy) and recovered Endocrine therapy Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy At least 28 days since prior radiotherapy and recovered No prior radiotherapy to more than 25% of bone marrow No concurrent palliative radiotherapy Surgery At least 14 days since prior major surgery and recovered Other At least 28 days since prior investigational drugs and recovered No other concurrent antitumor therapy
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: irinotecan<br>irinotecan | Drug: irinotecan<br> <br> * Other names: camptosar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer