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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001504 |
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.
Condition | Intervention | Phase |
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Breast Cancer Breast Neoplasm |
Drug: 9-cis-Retinoic Acid |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients |
Estimated Enrollment: | 18 |
Study Start Date: | May 1996 |
Estimated Study Completion Date: | January 2002 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Study ID Numbers: | 960080, 96-C-0080 |
Study First Received: | November 3, 1999 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00001504 |
Health Authority: | United States: Federal Government |
Retinoids Biomarkers |
Alitretinoin Skin Diseases Isotretinoin Tretinoin |
Breast Neoplasms Tamoxifen Breast Diseases |
Keratolytic Agents Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Dermatologic Agents Pharmacologic Actions |