Brief Title
Liposomal Doxorubicin and Etoposide in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
Official Title
A Phase I Study of Liposomal Doxorubicin (Doxil) and Prolonged Etoposide As Second Line Therapy in Ovarian, Tubal and Peritoneal Carcinoma
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of
liposomal doxorubicin and etoposide in treating patients who have recurrent or persistent
ovarian, fallopian tube, or peritoneal cancer.
Detailed Description
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.
Study Phase
Phase 1
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
etoposide
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
May 1998
Primary Completion Date
July 2002
Eligibility 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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Peter G. Rose, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00003380
Organization ID
CDR0000066375
Secondary IDs
GOG-9704
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Peter G. Rose, MD, Study Chair, The Cleveland Clinic
Verification Date
October 2002