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

Alternate Title

Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	Other	BIDMC-E-010405FB NEDH-E-010405FB, NCT00055614

Objectives

1. Determine the maximum tolerated dose and duration of prolonged topotecan as maintenance in patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer with complete clinical response after platinum-based chemotherapy.
2. Determine the safety of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal serous cancer
  • Stage IIIB, IIIC, or IV
  • Surgically staged and debulked



• Complete clinical response after first-line platinum-based chemotherapy (cisplatin or carboplatin) defined by all of the following criteria:
  • No evidence of cancer by history or physical examination
  • CA 125 no greater than 35 units/mL
  • No evidence of residual cancer on CT scan of the abdomen/pelvis and chest x-ray



• Must have received at least 5 courses of first-line chemotherapy

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent immunotherapy

Chemotherapy

• See Disease Characteristics
• At least 3 weeks since prior first-line chemotherapy
• At least 3 years since other prior chemotherapy (other than first-line chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer)
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy

Radiotherapy

• No prior abdominopelvic radiotherapy
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• No concurrent surgery

Other

• No other concurrent antitumor therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count at least 1,200/mm³
• Platelet count at least 90,000/mm³

Hepatic

• Bilirubin normal
• ALT and AST less than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase less than 1.5 ULN

Renal

• Creatinine clearance at least 60 mL/min

Expected Enrollment

A total of 20 patients will be accrued for this study.

Outline

This is a dose-escalation study.

Patients receive oral topotecan twice daily for 21 days. Treatment repeats every 28 days for up to 6 months in the absence of unacceptable toxicity or disease progression.

Patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent courses. The maximum tolerated dose is defined as the dose tolerated by the majority of the patients.

Patients are followed every 2 months for at least 6 months.

Trial Contact Information

Trial Lead Organizations

Beth Israel Deaconess Medical Center

Stephen Cannistra, MD, Protocol chair		Ph: 617-667-4283 Email: scannist@bidmc.harvard.edu

Registry Information
Official Title		Phase I Study of Oral Topotecan as Consolidation for Patients with Mullerian Origin Tumors (Ovary, Tube, Peritoneum)
Trial Start Date		2002-05-07
Registered in ClinicalTrials.gov		NCT00055614
Date Submitted to PDQ		2002-11-13
Information Last Verified		2007-04-09

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