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

NCT ID: NCT00003732

Last Updated: 2013-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-09-30
• Study Completion Date: 2005-09-30

Brief Summary

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.

Detailed 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)

Conditions

Ovarian Cancer

Keywords

stage IIB ovarian epithelial cancer; stage IIC ovarian epithelial cancer; stage IIIA ovarian epithelial cancer; stage IIIB ovarian epithelial cancer; stage IIIC ovarian epithelial cancer; stage IV ovarian epithelial cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

topotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Principal Investigators

Svend Aage Engelholm, MD

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

Rigshospitalet - Copenhagen University Hospital

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

CDR0000066847

Identifier Type: REGISTRY

Identifier Source: secondary_id

DAN-104864-A/373

Identifier Type: -

Identifier Source: secondary_id

EU-98052

Identifier Type: -

Identifier Source: secondary_id

SB-104864-A/373

Identifier Type: -

Identifier Source: secondary_id

SB-104864/373

Identifier Type: -

Identifier Source: secondary_id

DAN-104864/373

Identifier Type: -

Identifier Source: org_study_id