A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

Keywords

ClinConnect Summary

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 carcinoge...

Gender

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Eligibility criteria

• 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 0-2.
• 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.
• Other:
• • 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.