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

March 3, 2008 updated by: National Cancer Institute (NCI)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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-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.

Study Type

Interventional

Enrollment

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1996

Study Completion

January 1, 2002

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

January 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 960080
  • 96-C-0080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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