NCT00001504

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started May 1996

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1996

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2002

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Breast CancerBreast Neoplasm

Keywords

RetinoidsBiomarkers

Interventions

9-cis-Retinoic AcidDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Fontana JA. Interaction of retinoids and tamoxifen on the inhibition of human mammary carcinoma cell proliferation. Exp Cell Biol. 1987;55(3):136-44. doi: 10.1159/000163409.

    PMID: 3666278BACKGROUND

  • Welsch CW, DeHoog JV. Retinoid feeding, hormone inhibition, and/or immune stimulation and the genesis of carcinogen-induced rat mammary carcinomas. Cancer Res. 1983 Feb;43(2):585-91.

    PMID: 6401220BACKGROUND

  • Jordan VC, Murphy CS. Endocrine pharmacology of antiestrogens as antitumor agents. Endocr Rev. 1990 Nov;11(4):578-610. doi: 10.1210/edrv-11-4-578. No abstract available.

    PMID: 2292243BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Alitretinoin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TretinoinVitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

May 1, 1996

Study Completion

January 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-01

Locations

US(1)