A Phase I Study of Paclitaxel, Carboplatin, and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal, and Tubal Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 8
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Not specified
- •Performance status:
- •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
- •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
- •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
- •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
- •Recovered from recent prior surgery
- •No prior anticancer therapy that would preclude study
排除标准
- 未提供