Brief Title
Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer
Official Title
A Phase I Study of Paclitaxel, Carboplatin, and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal, and Tubal 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, paclitaxel, and carboplatin in treating patients who have untreated ovarian, peritoneal, or fallopian tube cancer.
Detailed Description
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.
Study Phase
Phase 1
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
carboplatin
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
Estimated Enrollment
48
Start Date
March 1999
Primary Completion Date
January 2007
Eligibility 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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Peter G. Rose, MD, ,
Location Countries
Norway
Location Countries
Norway
Administrative Informations
NCT ID
NCT00003385
Organization ID
CDR0000066381
Secondary IDs
GOG-9703
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Peter G. Rose, MD, Study Chair, MetroHealth Cancer Care Center at MetroHealth Medical Center
Verification Date
September 2003