PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES
paclitaxel
+ cisplatin
+ topotecan hydrochloride
Urogenital Diseases+21
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: December 1, 1996
Actual date on which the first participant was enrolled.PRIMARY OBJECTIVES: I. Determine the maximum tolerated doses of paclitaxel, cisplatin, and topotecan administered together with or without filgrastim (G-CSF) in patients with newly diagnosed advanced ovarian cancer. II. Describe and quantitate the clinical toxic effects of combination chemotherapy with paclitaxel, cisplatin, and topotecan with or without G-CSF. III. Assess preliminary evidence of antitumor activity of this combination chemotherapy in these patients. OUTLINE: This is a dose escalation study of topotecan. Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed as clinically indicated.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.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.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Histologically confirmed epithelial ovarian carcinoma No borderline ovarian carcinoma Stage III/IV disease that has been suboptimally or optimally debulked The following histologies are eligible: Adenocarcinoma (unspecified) Mucinous cystadenocarcinoma Clear cell adenocarcinoma Serous cystadenocarcinoma Endometrioid adenocarcinoma Transitional cell carcinoma Malignant Brenner's tumor Undifferentiated carcinoma Mixed epithelial carcinoma Extraovarian papillary serous cystadenocarcinoma Measurable or evaluable disease Performance status - GOG 0-1 Enabling completion of at least 2 courses of therapy Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min No myocardial infarction within 6 months No congestive heart failure No unstable or uncontrolled angina No history of cardiac arrhythmia requiring anti-arrhythmia medication No uncontrolled hypertension No hypersensitivity to E. coli-derived drug preparation No active infection No sensory neuropathy No other malignancies within the past 5 years except nonmelanomatous skin cancer No prior chemotherapy No prior radiotherapy Recovered from any recent surgery
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
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 1 location
Gynecologic Oncology Group of Arizona
Phoenix, United StatesOpen Gynecologic Oncology Group of Arizona in Google Maps