NCT00003536撤回2 期
Phase II Randomized Study of Methotrexate With or Without Antineoplaston A10 Capsules in Women With Advanced Breast Cancer
Burzynski Research Institute2 个研究点 分布在 1 个国家开始时间: 2003年1月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
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. Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. It is not yet known whether giving antineoplastons with chemotherapy is more effective than chemotherapy alone in treating women with refractory breast cancer.
PURPOSE: This randomized phase II trial is studying methotrexate alone to see how well it works campared to methotrexate and antineoplaston therapy in treating postmenopausal women with advanced refractory breast cancer.
详细描述
OBJECTIVES:
- Compare the antitumor activity of antineoplaston A10 with methotrexate vs methotrexate alone, in terms of objective tumor response, in women with advanced breast cancer.
- Compare the adverse effects of and tolerance to these regimens in these patients.
OUTLINE: This is a randomized study.
- Arm I: Patients receive gradually escalating doses of oral antineoplaston A10 capsules 7 times daily until the maximum tolerated dose is reached, followed by oral methotrexate capsules 2 to 3 times per day in five days on and five days off courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral methotrexate alone on the same schedule as in arm I.
Tumors are measured every 4 months for 2 years, every 6 months for years 3 and 4, and then annually for years 5 and 6.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed advanced breast cancer that is refractory or unlikely to respond to hormonal therapy AND failed at least 1 prior chemotherapy regimen
- •Symptomatic lymphangitic pulmonary dissemination allowed
- •Extensive visceral metastasis allowed
- •Patients who are refractory or who have failed to respond after at least 8 weeks of methotrexate or a methotrexate-containing regimen are not eligible
- •Measurable disease
- •No bone metastases
- •Hormone receptor status:
- •Estrogen receptor negative
- •PATIENT CHARACTERISTICS:
- •Postmenopausal
- •Menopausal status:
- •Postmenopausal
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2.5 mg/dL
- •SGOT no greater than 2 times normal
- •Blood ammonia normal
- •No hepatic failure
- •BUN less than 60 mg/dL
- •Creatinine no greater than 2.5 mg/dL
- •Creatinine clearance greater than 60 mL/min
- •No chronic renal failure
- •Cardiovascular:
- •No severe heart disease
- •No severe lung disease
- •No serious active infections or fever
- •No other concurrent serious disease
- •No prior or concurrent secondary malignancies within the past 2 years
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy and recovered
- •No concurrent biologic therapy for metastatic breast cancer
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior cytotoxic chemotherapy and recovered
- •No other concurrent chemotherapy for metastatic breast cancer
- •Endocrine therapy:
- •See Disease Characteristics
- •At least 4 weeks since prior hormonal therapy and recovered
- •No concurrent hormonal therapy for metastatic breast cancer
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy for metastatic breast cancer
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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