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

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.

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.

Eligibility Criteria:
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