Search / Trial NCT00001504

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

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

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Trial Information

Current as of October 22, 2024

Completed

Keywords

Retinoids Biomarkers

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-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

ALL

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.

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0