Overview

Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Status:
Unknown status
Trial end date:
1969-12-31
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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating patients who have stage III or stage IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Herbert Irving Comprehensive Cancer Center
Treatments:
Carboplatin
Docetaxel
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed previously untreated ovarian cancer, fallopian tube
carcinoma, papillary serous cancer of the uterus, or primary peritoneal carcinoma

- Suboptimally debulked stage III or suboptimally or optimally debulked stage IV

- Measurable or evaluable disease

- CNS lesions, lytic bone lesions, and radiated lesions (unless there is documented
progression after radiotherapy) are not considered measurable

- CA 125 levels above 49 units/mL in the absence of cirrhosis or nonmalignant gross
ascites are considered evaluable

- Ineligible for other high-priority national or institutional study

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ECOG 0-1

Life expectancy:

- More than 2 months

Hematopoietic:

- WBC greater than 3,000/mm3

- Platelet count greater than 100,000/mm3

Hepatic:

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- SGOT and/or SGPT less than 2.5 times ULN OR

- SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than
ULN OR

- Alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT no greater than
ULN

- No SGOT and/or SGPT greater than 1.5 times ULN with alkaline phosphatase greater than
2.5 times ULN

- Alkaline phosphatase less than 350 U/L

Renal:

- BUN less than 1.5 times normal

- Creatinine less than 1.5 times ULN

Other:

- No other malignancy within the past 5 years except curatively treated carcinoma in
situ of the cervix or skin cancer

- No other serious medical or psychiatric illness

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormone therapy

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy

Surgery:

- See Disease Characteristics