SWOG clinical trial number
S0025

Phase II Trial of Irinotecan (Camptosar) for Patients with Platinum and Taxane Refractory Ovarian, Peritoneal or Fallopian Tube Cancer

Closed
Phase
Accrual
5%
Abbreviated Title
OVARIAN
Activated
02/15/2003
Closed
08/15/2003
Participants
NCORP, Members, Medical Oncologists, Surgeons, Pathologists

Research committees

Gynecologic Cancer

Treatment

Irinotecan

Eligibility Criteria Expand/Collapse

Histologically or pathologically confirmed epithelial carcinoma of ovary, peritoneum or fallopian tubes. Mixed mullerian and borderline ovarian tumors not allowed. Must be surgically staged as Stage III or IV at initial diagnosis. If tumor is known to be KIT (CD117) or PDGFR positive, must be offered S0211 if available. Must have measurable disease. Must have relapsed within 6 months of frontline concurrent or sequential platinum and taxane OR had best response of increasing disease during this regimen. One additional prior chemo regimen allowed. Prior hormonal therapy allowed. No more than one prior biological response modifier. No prior topotecan or any other topoisomerase I inhibitor. May have received prior RT if completed more than 28 days prior to registration and as long as it encompassed no more than 25% of bone barrow and patient has recovered from all effects. Measurable disease must remain outside the RT field. No major surgery within 14 days prior to registration and must have recovered from effects. Debulking surgery allowed as long as measurable disease remains after surgery. CA-125 within 28 days prior. No recent myocardial infarction, angina pectoris, uncontrolled congestive heart failure, or uncontrolled cardiac arrhythmia. Zubrod performance status 0-2. No plans for concurrent treatment or palliative radiation. No pregnant or nursing women. No other prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.