A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Response Rate (Complete and Partial)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving isotretinoin and interferon alpha-2b together with paclitaxel may reduce drug resistance and allow the tumor cells to be killed.
PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alpha-2b together with paclitaxel works in treating patients with stage IV, recurrent, or persistent cervical cancer.
详细描述
OBJECTIVES:
- Determine the response in patients with stage IVB, recurrent, or persistent cervical cancer treated with isotretinoin, interferon alpha-2b, and paclitaxel.
OUTLINE: This is a multicenter study.
Patients receive oral isotretinoin and interferon alpha-2b subcutaneously once daily on days 1-4 and paclitaxel IV over 3 hours on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 27-66 patients will be accrued for this study.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
- Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
- Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
- Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days
干预措施: recombinant interferon alpha-2b (Biological)
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
- Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
- Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
- Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days
干预措施: isotretinoin (Drug)
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
- Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
- Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
- Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days
干预措施: paclitaxel (Drug)
结局指标
主要结局
Response Rate (Complete and Partial)
时间窗: 8 years
All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.
次要结局
- The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.(8 years)
- The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.(8 years)