Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer

NYU Langone Health

Status and phase

Completed

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: topotecan hydrochloride

Drug: paclitaxel

Drug: cisplatin

Drug: carboplatin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00005051

CDR0000067644

NYU-9913

NCI-G00-1720

Details and patient eligibility

About

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 combination chemotherapy in treating patients who have advanced ovarian epithelial cancer.

Full description

OBJECTIVES:

Determine the toxicity and tolerance of sequential therapy with prolonged
Determine the response rate and time to progression in this patient
Determine the relative pharmacokinetics of IV and prolonged oral administration of topotecan in the same patients and compare the pharmacodynamics of topo-1 inhibition when given by IV or oral route.

OUTLINE:

Regimen A: Patients receive cisplatin IV over 60-90 minutes on day 1 of each course. Topotecan IV is administered continuously on days 1-14 of course 1. Oral topotecan is administered twice daily on days 1-14 for courses 2, 3, and 4. Treatment repeats every 28 days for 4 courses.
Regimen B: After completion of regimen A, patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.

PROJECTED ACCRUAL: A total of 30 patients (15 per arm) will be accrued for this study.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed advanced ovarian epithelial carcinoma, regardless of quantity of disease post-surgery
- Stage IC, II, III, or IV

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

SGOT no greater than 3 times upper limit of normal
Bilirubin no greater than 2.0 mg/dL
No clinically significant hepatic disorder

Renal:

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance greater than 60 mL/min
No clinically significant renal disorder

Cardiovascular:

No clinically significant cardiovascular condition

Other:

Normal GI function allowing reliable administration of oral medication
No active infection requiring systemic medical therapy within past week
No other clinically significant medical condition (e.g., endocrine/metabolic or autoimmune disorder)
No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No dementia or altered mental status that would preclude consent
Not pregnant
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy: