Expired Study
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Boston, Massachusetts 02215


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.


Study summary:

OBJECTIVES: - 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. - Determine the safety of this regimen in these patients. 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. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.


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 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Granulocyte count at least 1,200/mm^3 - Platelet count at least 90,000/mm^3 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 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


NCT ID:

NCT00055614


Primary Contact:

Study Chair
Stephen A. Cannistra, MD
Beth Israel Deaconess Medical Center


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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