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

Phase 2

Completed

Conditions: Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving topotecan in different dosing schedules may kill more tumor cells.

PURPOSE: This phase II trial is studying how well topotecan works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Detailed Description: OBJECTIVES:

Primary

* Determine the antitumor activity of topotecan, in terms of frequency and duration of tumor response, in patients with recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer.

* Determine the nature and degree of toxicity of this regimen in these patients.

Secondary

* Determine the duration of progression-free survival and overall survival in patients treated with these regimens.

* Determine the effects of prognostic variables (i.e., initial performance status, age, and mucinous or clear cell histology) in patients treated with these regimens.

OUTLINE: This is a multicenter study.

Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 38-110 patients (19-55 per treatment arm) will be accrued for this study within 15-30 months.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle	topotecan hydrochloride	Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle until disease progression or adverse effects prohibit further therapy
Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle	topotecan hydrochloride	Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle until disease progression or adverse effects prohibit further therapy

Primary Outcome Measures

Name	Time	Method
Objective Tumor Response	Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal	Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0	Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

Secondary Outcome Measures

Name	Time	Method
Reason Off Study Therapy	study entry through end of study treatment, up to 5 years

Locations (78): Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸
Hartford, Connecticut, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
🇺🇸
New Britain, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
🇺🇸
Newark, Delaware, United States
Washington Cancer Institute at Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
MBCCOP - Medical College of Georgia Cancer Center
🇺🇸
Augusta, Georgia, United States
Rush-Copley Cancer Care Center
🇺🇸
Aurora, Illinois, United States
University of Illinois Cancer Center
🇺🇸
Chicago, Illinois, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Hinsdale Hematology Oncology Associates
🇺🇸
Hinsdale, Illinois, United States
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Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States