Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

• Status: Completed
• Trial end date: 2007-10-01
• 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 I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal serous cancer

• Stage IIIB, IIIC, or IV

• Surgically staged and debulked

• Complete clinical response after first-line platinum-based chemotherapy (cisplatin or carboplatin) defined by all of the following criteria:

• No evidence of cancer by history or physical examination

• CA 125 no greater than 35 units/mL

• No evidence of residual cancer on CT scan of the abdomen/pelvis and chest x-ray

• Must have received at least 5 courses of first-line chemotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count at least 1,200/mm^3

• Platelet count at least 90,000/mm^3

Hepatic

• Bilirubin normal

• ALT and AST less than 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase less than 1.5 ULN

Renal

• Creatinine clearance at least 60 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy

Chemotherapy

• See Disease Characteristics

• At least 3 weeks since prior first-line chemotherapy

• At least 3 years since other prior chemotherapy (other than first-line chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer)

• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy

Radiotherapy

• No prior abdominopelvic radiotherapy

• No concurrent radiotherapy

Surgery

• See Disease Characteristics

• No concurrent surgery

Other

• No other concurrent antitumor therapy