A Phase II Trial Using Multiple Cycles of High Dose Sequential Carboplatin, Paclitaxel and Topotecan With Peripheral Blood Stem Cell (PBSC) Support as Initial Chemotherapy in Patients With Optimally Debulked Stage III Ovarian and Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Complete response defined as complete disappearance of all measurable and evaluable tumor documented at second-look surgery
研究概览
简要总结
Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have undergone surgery for stage III ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
详细描述
OBJECTIVES:
I. Determine the safety and feasibility of multiple courses of high dose carboplatin, paclitaxel, and topotecan as initial chemotherapy combined with autologous peripheral blood stem cell transplantation in patients with optimally debulked stage III ovarian or primary peritoneal carcinoma.
II. Determine the pathological complete response rate, disease free survival, and overall survival in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Mobilization and harvest: Within 8 weeks of surgical debulking, patients receive cyclophosphamide IV over 1 hour, followed 4 hours later by paclitaxel IV over 24 hours. Patients receive filgrastim (G-CSF) subcutaneously (SQ) daily beginning 24 hours after completion of paclitaxel infusion and continuing until blood counts recover and autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven optimally debulked stage III ovarian or primary peritoneal carcinoma
- •Any of the following subtypes:
- •Serous adenocarcinoma
- •Mucinous adenocarcinoma
- •Clear cell carcinoma
- •Transitional cell carcinoma
- •Endometrioid adenocarcinoma
- •Undifferentiated adenocarcinoma
- •Mixed epithelial adenocarcinoma
- •Adenocarcinoma, not otherwise specified
- •No ovarian carcinoma of low malignant potential (borderline)
- •Concurrent superficial endometrial or cervical carcinoma allowed if ovarian carcinoma more life threatening or limiting
- •Must have undergone appropriate primary surgical staging and debulking for ovarian carcinoma and have less than 1 cm of residual disease
- •No more than 8 weeks since prior surgical debulking
- •Must have Hickman catheter in place or be eligible for placement
- •No CNS involvement
- •Performance status - GOG 0 or 1
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT or SGPT no greater than 2 times upper limit of normal
- •No active hepatitis
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •No renal failure
- •Curatively treated ureteral obstruction allowed if above creatinine measurements met
- •No congestive heart failure
- •No myocardial infarction within the past 6 months
- •No significant arrhythmias requiring medication
- •No poorly controlled systolic or diastolic hypertension (diastolic blood pressure consistently greater than 100 mm Hg)
- •No significant nonneoplastic pulmonary disease
- •No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •HIV negative
- •No other severe medical or psychiatric illness including, but not limited to the following:
- •Acute infection
- •Active peptic ulcer disease
- •Uncontrolled diabetes mellitus
- •Prior hospitalization for psychiatric illness, including severe depression or psychosis
- •Concurrent alcohol or drug abuse
- •No prior chemotherapy for this malignancy
- •No radiotherapy to greater than 25% of bone marrow
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
Treatment (Combination chemotherapy, PBSC)
See detailed description.
干预措施: Carboplatin (Drug)
Treatment (Combination chemotherapy, PBSC)
See detailed description.
干预措施: Cyclophosphamide (Drug)
Treatment (Combination chemotherapy, PBSC)
See detailed description.
干预措施: Filgrastim (Biological)
Treatment (Combination chemotherapy, PBSC)
See detailed description.
干预措施: Paclitaxel (Drug)
Treatment (Combination chemotherapy, PBSC)
See detailed description.
干预措施: Peripheral Blood Stem Cell Transplantation (Procedure)
Treatment (Combination chemotherapy, PBSC)
See detailed description.
干预措施: Topotecan Hydrochloride (Drug)
结局指标
主要结局
Complete response defined as complete disappearance of all measurable and evaluable tumor documented at second-look surgery
时间窗: Up to 11 years
Indication of excessive toxicity defined as hospitalization > 14 days per course, delay of day 1 therapy > 14 days, or grade 3 (irreversible) or grade 4 vital organ toxicity (non-hematologic)
时间窗: Up to 11 years
次要结局
- Overall survival(Up to 11 years)
- PFS(Up to 11 years)