Status:
COMPLETED
A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Breast Neoplasm
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
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 fo...
Detailed Description
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-...
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.
Key Trial Info
Start Date :
May 1 1996
Trial Type :
INTERVENTIONAL
End Date :
January 1 2002
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00001504
Start Date
May 1 1996
End Date
January 1 2002
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892