A Phase I Study of Liposomal Doxorubicin (Doxil) and Prolonged Etoposide As Second Line Therapy in Ovarian, Tubal and Peritoneal Carcinoma
etoposide
+ pegylated liposomal doxorubicin hydrochloride
Urogenital Diseases+23
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: May 1, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the optimal dose of doxorubicin HCl liposomal and prolonged oral etoposide in patients with recurrent or persistent ovarian, tubal, and peritoneal carcinoma. II. Determine the nature and degree of toxicity of this therapy in these patients. III. Evaluate the response rate of patients with measurable disease. OUTLINE: This is a dose escalation, multicenter study of etoposide and doxorubicin HCl liposome. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by oral etoposide for 8-14 days beginning on day 2. For patients who achieve partial or complete response, treatment repeats every 4 weeks for 1 year in the absence of disease progression or unacceptable toxicity. For patients with stable disease, treatment repeats every 4 weeks for 6 months. In the absence of dose limiting toxicity (DLT) in the first 3 patients treated, subsequent cohorts of 3-6 patients each receive doses of etoposide for more prolonged periods. After 14 days of oral etoposide, the dose of doxorubicin HCl liposome is escalated. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience DLT. Patients are followed every 3 months for 1 year, then until death. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 1 year.
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.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 proven recurrent or persistent ovarian, tubal, or peritoneal carcinoma of the following cell types: Serous adenocarcinoma Mucinous adenocarcinoma Clear cell adenocarcinoma Transitional cell Endometrioid adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Malignant Brenner tumor Adenocarcinoma not otherwise specified Must not be eligible for any other higher priority phase II or phase III GOG protocol PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT/SGPT/GGT no greater than 2.5 times normal Alkaline phosphatase no greater than 2.5 times normal No acute hepatitis Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF within normal range as determined by MUGA No congestive heart failure or unstable angina No myocardial infarction within the past 6 months Prior abnormal cardiac conduction (e.g., bundle branch block, heart block) allowed if stable for at least 6 months Other: No significant infection No septicemia Body surface area at least 1 m2 Adequate intestinal function (i.e., does not require IV hydration or nutritional support) No severe gastrointestinal bleeding No other invasive malignancies within the past 5 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy and recovered Chemotherapy: Must have received at least 1 prior cisplatin-paclitaxel based regimen At least 3 weeks since prior chemotherapy and recovered No prior anthracycline therapy Endocrine therapy: At least 3 weeks since prior endocrine therapy and recovered Radiotherapy: No prior radiotherapy to more than 10% of bone marrow Surgery: At least 3 weeks since prior surgery and recovered
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 63 locations
University of Alabama Comprehensive Cancer Center
Birmingham, United StatesOpen University of Alabama Comprehensive Cancer Center in Google MapsCCOP - Greater Phoenix
Phoenix, United StatesUSC/Norris Comprehensive Cancer Center
Los Angeles, United StatesJonsson Comprehensive Cancer Center, UCLA
Los Angeles, United States