A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
研究概览
简要总结
This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the study if medically appropriate.
详细描述
This is a Phase I study of the combination tamoxifen and 9-cis-Retinoic acid in patients with breast cancer. The primary objective of the study is; 1) to determine the maximum tolerated dose of 9-cis-Retinoic acid in combination with Tamoxifen and to determine the overall and dose limiting toxicities. Other objectives are: 2) to determine the effect of Tamoxifen on the pharmacokinetics of 9-cis-Retinoic acid; 3) to evaluate the anti-tumor activity of this combination therapy within the context of a phase I study; 4) and to determine the expression of surrogate biomarkers of breast carcinogenesis before and after treatment.
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:
- •All patients must have histologically documented diagnosis of Stage III, or IV breast carcinoma.
- •Patients with stage III that has completed chemotherapy: Estrogen receptor (ER) or progesterone receptor (PR) positive tumor required if premenopausal. Either ER/PR-positive or -negative tumor allowed if postmenopausal and have received prior chemotherapy.
- •Patients may have stage IV with ER/PR-positive or -negative tumor.
- •No CNS metastases, pseudotumor cereri, or seizures.
- •PRIOR/CONCURRENT THERAPY:
- •Patients who have ecovered from the toxic effects of prior therapy will be eligible.
- •Patients with prior tamoxifen will be allowed to participate. At least 3 weeks must have elapsed since the last dose of chemotherapy.
- •PATIENT CHARACTERISTICS:
- •Age: 18 and over.
- •Sex: Men and women.
- •Menopausal status: Any status.
- •Patients must have a performance status of ECOG 0-
- •Patients must have Hematopoietic criteria of:
- •ANC at least 1,500/mm(3).
- •Platelet count at least 90,000/mm(3).
- •Patients must have Hepatic criteria of:
- •In the absence of tumor involvement:
- •Bilirubin no greater than twice normal;
- •SGOT no greater than twice normal;
- •Alkaline phosphate no greater than twice normal;
- •Fasting triglycerides less than 3 times normal.
- •Patients must have Renal criteria of:
- •Serum creatinine no greater than 1.5 mg/dL OR;
- •Creatinine clearance at least 60 mL/min.
- •No allergy to study medications.
- •No nonmalignant systemic disease that would preclude therapy.
- •No second malignancy within 5 years except: Curatively treated basal cell skin carcinoma. Cervical carcinoma in situ.
- •Pregnant women will be excluded.
- •Negative pregnancy test required within 7 days prior to entry.
- •Adequate contraception required for 4 weeks prior to, during, and for 1 year after study.
- •Patients must give informed consent.
- •Patients who are poor medical or psychiatric risks will be eligible.
排除标准
- 未提供