A Phase I Study of Gemcitabine/Topotecan in Combination in Refractory Ovarian Cancer or Cancer of the Fallopian Tube
filgrastim
+ gemcitabine hydrochloride
+ topotecan hydrochloride
Urogenital Diseases+18
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: May 1, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the maximum tolerated doses of the combination of gemcitabine and topotecan administered with and without filgrastim (G-CSF) in patients with refractory ovarian or fallopian tube cancer. Describe and quantitate the clinical toxicities of these regimens in this patient population. OUTLINE: This is a dose escalation study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and topotecan IV over 30 minutes on days 2-4. Some patients receive filgrastim (G-CSF) subcutaneously on days 9-14. Treatment repeats every 28 days for up to 5-10 courses. 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 below that at which 2 of 6 patients experience dose limiting toxicity (DLT). Dose escalation of gemcitabine then continues in cohorts of 3-6 patients until the MTD is determined. The MTD is defined as the dose below that at which 2 of 6 patients experience DLT. Patients are followed every 2-3 months for 2 years, every 6 months for 3 years, then annually thereafter. PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically documented refractory or recurrent ovarian epithelial or fallopian tube cancer No borderline ovarian cancer Extra-ovarian papillary serous tumors eligible Must not be eligible for any higher priority phase II or III GOG protocol PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: SGOT no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 1.5 mg/dL Elevated levels of alkaline phosphatase allowed Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No angina pectoris or clinically significant multifocal uncontrolled cardiac dysrhythmias No uncontrolled hypertension Other: No other active malignancy No prior malignancy within the past 5 years except nonmelanomatous skin cancer No active infection No underlying medical problem that would prevent compliance No known hypersensitivity to E. coli-derived drug preparations Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Must have received at least 1 prior platinum- and paclitaxel-based regimen At least 4 weeks since prior chemotherapy No prior topotecan and/or gemcitabine No prior chemotherapy for a different prior malignancy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 10% of bone marrow At least 2 weeks since limited field radiation therapy Surgery: Not specified
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
Community Hospital of Los Gatos
Los Gatos, United StatesOpen Community Hospital of Los Gatos in Google MapsChao Family Comprehensive Cancer Center
Orange, United StatesWomen's Cancer Center
Palo Alto, United StatesUniversity of Chicago Cancer Research Center
Chicago, United States