Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Boston, Massachusetts 02215


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.


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



Primary Contact:

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

Backup Contact:


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: June 25, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.