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

• Status: Terminated
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Irinotecan

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