Know Cancer

or
forgot password

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


Phase 1
N/A
N/A
Not Enrolling
Both
Breast Cancer, Breast Neoplasm

Thank you

Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

960080

NCT ID:

NCT00001504

Start Date:

May 1996

Completion Date:

January 2002

Related Keywords:

  • Breast Cancer
  • Breast Neoplasm
  • Retinoids
  • Biomarkers
  • Breast Neoplasms
  • Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892