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

Rigshospitalet, Denmark80 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Ovarian Cancer

Interventions

carboplatinDRUG

paclitaxelDRUG

topotecan hydrochlorideDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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: * No concurrent immunotherapy Chemotherapy: * No prior camptothecin analogue * No prior chemotherapy for ovarian cancer * No other concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * No concurrent hormonal therapy other than estrogen replacement Radiotherapy: * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * At least 30 days or 5 half-lives since any prior investigational therapy * No other concurrent investigational therapy * No concurrent metoclopramide or cisapride

Locations (1)

Rigshospitalet - Copenhagen University Hospital

Copenhagen, Denmark

Outcomes

Primary Outcomes

Maximum tolerated dose and dose-limiting toxicity of topotecan

Toxic effects

Antitumor activity

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.