Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over Pharmaceutical / Industry DAN-104864/373 DAN-104864-A/373, EU-98052, SB-104864-A/373, SB-104864/373, NCT00003732

Objectives

1. 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)
2. Evaluate the anti-tumor activity of this regimen in this patient population.

Entry 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

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

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

Expected Enrollment

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)

Outcomes

Maximum tolerated dose and dose-limiting toxicity of topotecan
Toxic effects
Antitumor activity

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.

Trial Contact Information

Trial Lead Organizations

Rigshospitalet - Copenhagen University Hospital

Svend Aage Engelholm, MD, Protocol chair		Ph: 45-3545-4088 Email: saengel@rh.dk

Denmark
	Copenhagen
	Rigshospitalet - Copenhagen University Hospital
		Svend Aage Engelholm, MD	Ph:  45-3545-4088
			Email: saengel@rh.dk

Registry Information
Official Title		A Phase I/II Study to Determine the Maximum Tolerated Doses of Oral Topotecan, Carboplatin and Paclitaxel Administered Every 21 Days to Patients with Epithelial Ovarian Cancer Stages IIb, IIc, III and IV
Trial Start Date		1998-09-01
Registered in ClinicalTrials.gov		NCT00003732
Date Submitted to PDQ		1998-12-29
Information Last Verified		2002-07-31

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