A Phase I Study of Paclitaxel, Carboplatin, and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal, and Tubal Carcinoma
N/A
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Trial Information
A Phase I Study of Paclitaxel, Carboplatin, and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal, and Tubal Carcinoma
OBJECTIVES:
- Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with
paclitaxel and carboplatin in patients with previously untreated ovarian epithelial,
peritoneal, or fallopian tube cancer.
- Determine the toxicity of this treatment regimen in these patients.
- Evaluate measurable disease in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of doxorubicin HCl liposome (LipoDox).
Patients receive LipoDox IV on day 1, carboplatin IV over 3 hours on days 1 and 22, and
paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days
for 4 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of LipoDox until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity. An additional cohort of 12 patients receives
LipoDox at the MTD with carboplatin and paclitaxel as above.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study within 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed previously untreated ovarian epithelial carcinoma,
peritoneal carcinoma, or fallopian tube carcinoma
- The following histologic epithelial cell types are eligible:
- Serous adenocarcinoma
- Endometrioid adenocarcinoma
- Mucinous adenocarcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Transitional cell
- Malignant Brenner tumor
- Adenocarcinoma not otherwise specified
- No more than 12 weeks since diagnosis
- No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Absolute granulocyte count at least 1,500/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT/SGPT no greater than 3 times normal
- Alkaline phosphatase no greater than 3 times normal
- Gamma-glutamyl-transferase no greater than 3 times normal
- No acute hepatitis
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance greater than 50 mL/min
Cardiovascular:
- LVEF normal by MUGA
- No unstable angina
- No myocardial infarction within the past 6 months
- Patients with abnormal cardiac conduction (e.g., bundle branch block or heart block)
are eligible if disease has been stable for the past 6 months
Other:
- No septicemia or severe infection
- No severe gastrointestinal bleeding
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- Recovered from recent prior surgery
Other:
- No prior anticancer therapy that would preclude study
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Peter G. Rose, MD
Investigator Role:
Study Chair
Investigator Affiliation:
MetroHealth Cancer Care Center at MetroHealth Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000066381
NCT ID:
NCT00003385
Start Date:
March 1999
Completion Date:
Related Keywords:
- Fallopian Tube Cancer
- Ovarian Cancer
- Primary Peritoneal Cavity Cancer
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
- stage III ovarian epithelial cancer
- stage IV 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
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
