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



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

For Condition: Breast Cancer,Breast Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 18

Location and Contact Information:

National Cancer Institute (NCI)
Bethesda,  Maryland,  20892
United States
 


Additional Information:
Study ID Numbers:  960080;  96-C-0080
Study Start Date: May 19, 1996
Record last reviewed: January 31, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001504

Other Breast Neoplasm Studies:
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2. Combination Chemotherapy (FLAC) Combined with Granulocyte-Macrophage Colony Stimulating Factor in Locally Advanced and Metastatic Breast Cancer

3. Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer

4. Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer

5. Docetaxel in Treating Patients With Solid Tumors

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