A Phase I Trial of Combination Carboplatin and Lipsomal Doxorubicin (Doxil) In Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
N/A
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Trial Information
A Phase I Trial of Combination Carboplatin and Lipsomal Doxorubicin (Doxil) In Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of doxorubicin HCl liposome (Doxil) when
combined with carboplatin in patients with recurrent ovarian, fallopian tube, or primary
peritoneal cancer. II. Determine the toxicity of this regimen in these patients. III.
Determine the rate of response in patients treated with this regimen.
OUTLINE: This is a dose escalation, multicenter study of doxorubicin HCl liposome (Doxil).
Patients receive Doxil IV over 1 hour and carboplatin IV on day 1. Treatment continues every
4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease
progression. Cohorts of 3-6 patients receive escalating doses of Doxil until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which 0 or 1
of 6 patients experience dose limiting toxicity. Patients are followed every 3 months for 2
years, then every 6 months for 3 years, and then annually thereafter until recurrence or
death.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study over 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven recurrent ovarian, tubal, or peritoneal
cancer that is platinum sensitive (i.e., 6 months from last chemotherapy) Maximum of 1
prior chemotherapy regimen comprised of no more than 6 treatments at first recurrence Must
have 1 of the following epithelial subtypes: Serous adenocarcinoma Endometrioid
adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell
adenocarcinoma Mixed epithelial carcinoma Transitional cell Malignant Brenner tumor
Adenocarcinoma not otherwise specified Measurable or evaluable disease Greater than 2 cm
by CT scan, if measurable
PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin normal SGOT,
SGPT, GGT, and alkaline phosphatase no greater than 2.5 times upper limit of normal No
acute hepatitis Renal: Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF
normal by MUGA No congestive heart failure No unstable angina No myocardial infarction
within the past 6 months Abnormal cardiac conduction (e.g., bundle branch block, heart
block) allowed if disease has been stable for at least 6 months Other: No septicemia or
significant infection No severe gastrointestinal bleeding No other malignancy within the
past 5 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No prior anthracycline therapy At least 3 weeks since other prior
chemotherapy for ovarian, fallopian tube, or peritoneal cancer and recovered Endocrine
therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: At least 3 weeks since
prior surgery for ovarian, fallopian tube, or peritoneal cancer and recovered Other: No
other prior cancer therapy that would preclude study therapy
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Michael Rodriguez, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospitals Seidman Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068160
NCT ID:
NCT00006235
Start Date:
Completion Date:
Related Keywords:
- Fallopian Tube Cancer
- Ovarian Cancer
- Primary Peritoneal Cavity Cancer
- recurrent ovarian epithelial cancer
- ovarian undifferentiated adenocarcinoma
- ovarian mixed epithelial carcinoma
- ovarian serous cystadenocarcinoma
- ovarian mucinous cystadenocarcinoma
- ovarian endometrioid adenocarcinoma
- ovarian clear cell cystadenocarcinoma
- fallopian tube cancer
- primary peritoneal cavity cancer
- Brenner tumor
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
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