Overview

Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer

Status:
Completed
Trial end date:
2006-08-01
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. Combining more than one drug may kill more tumor cells. It is not yet known if paclitaxel plus carboplatin is more effective with or without topotecan for ovarian epithelial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel plus carboplatin with or without topotecan in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AGO Study Group
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Paclitaxel
Topotecan
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IIB, III, or IV ovarian epithelial
carcinoma, fallopian tube, or extraovarian papillary serous carcinoma extending to the
ovary No mixed epithelial/non-epithelial tumors (e.g., mixed Mullerian tumors) No tumors of
low malignant potential (e.g., borderline tumors) No symptomatic brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100%
Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times
the upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Renal:
Creatinine no greater than 1.25 times ULN Estimated glomerular filtration rate at least 60
mL/min Cardiovascular: No history of congestive heart failure (even if medically
controlled) No New York Heart Association class III or IV heart disease No myocardial
infarction within the past 6 months No history of atrial or ventricular arrhythmias Other:
No motor or sensory neurologic pathology or symptoms greater than grade 1 No active
infection or other serious medical condition that would preclude study No prior allergy to
drug containing Cremophor EL No dementia or significantly altered mental state that would
preclude informed consent No complete bowel obstruction No other prior malignancy except
curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not
pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent WBC
transfusions Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine
therapy: No concurrent hormonal therapy Radiotherapy: No prior radiotherapy No concurrent
radiotherapy Surgery: No more than 6 weeks since prior definitive laparotomy and recovered
Other: No other concurrent antineoplastic agents No other concurrent investigational drugs