Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer

Rigshospitalet

Status and phase

Completed

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: paclitaxel

Drug: carboplatin

Drug: topotecan hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00003732

SB-104864-A/373

DAN-104864-A/373

EU-98052

CDR0000066847 (Registry Identifier)

SB-104864/373

DAN-104864/373

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of topotecan combined with carboplatin and paclitaxel in treating patients who have stage II, stage III, or stage IV ovarian cancer.

Full description

OBJECTIVES:

Determine the maximum tolerated dose, dose-limiting toxicity, and quantitative and qualitative toxic effects of oral topotecan combined with intravenous carboplatin and paclitaxel in patients with stage IIB, IIC, III, or IV ovarian epithelial cancer. (phase I closed to accrual 12/21/00)
Evaluate the anti-tumor activity of this regimen in this patient population.

OUTLINE: This is a multicenter, dose-escalation study of topotecan.

Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 5. Courses repeat every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Phase I: Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. (phase I closed to accrual 12/21/00)
Phase II: An additional 50 patients receive up to 6 courses of treatment as in phase I at the MTD.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 80 patients (30 in phase I and 50 in phase II) will be accrued for this study. (phase I closed to accrual 12/21/00)

Enrollment

80 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed stage IIB, IIC, III, or IV ovarian epithelial cancer
Measurable or evaluable lesion or microscopic residual disease after first surgery (phase II patients)
No brain and/or leptomeningeal metastases by CT scan or MRI unless asymptomatic without corticosteroid therapy

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

At least 3 months

Hematopoietic:

Hemoglobin at least 9.0 g/dL
WBC at least 3,500/mm3
Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN) unless liver metastases present
Alkaline phosphatase no greater than 2 times ULN*
SGOT no greater than 2 times ULN* NOTE: *No greater than 5 times ULN if liver metastases present

Renal:

Creatinine no greater than 1.5 times ULN
Creatinine clearance at least 60 mL/min

Cardiovascular:

No symptomatic cardiac disease, including clinical congestive heart failure or arrhythmias requiring treatment
No myocardial infarction within the past 3 months

Other:

No other malignancy except basal or squamous cell skin cancer or carcinoma in situ of the cervix
No uncontrolled infection
No complete bowel obstruction or other condition that would affect GI absorption or motility
No concurrent medical condition for which treatment with platinum, taxane, or camptothecin analogues are contraindicated
No other concurrent medical conditions that would preclude study
No mental disease
No history of allergy to platinum or taxanes, including drugs containing cremophor (e.g., cyclosporine or vitamin K)
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy: