Overview

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