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Chemoprevention of Skin Cancers With DFMO: A Controlled, Randomized Clinical Trial


Phase 3
21 Years
N/A
Open (Enrolling)
Both
Non-Melanomatous Skin Cancer

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Trial Information

Chemoprevention of Skin Cancers With DFMO: A Controlled, Randomized Clinical Trial


OBJECTIVES: I. Compare the rate of new skin cancer in patients with previously treated stage
0, I, or II basal or squamous cell skin cancer treated with eflornithine (DFMO) vs placebo.
II. Determine whether inhibition of TPA-induced ornithine decarboxylase activity serves as
an intermediary marker for response to DFMO in these patients. III. Determine whether
inhibition of skin polyamine levels serves as an intermediary marker for response to DFMO in
these patients. IV. Assess the long term toxic effects of this treatment in these patients.

OUTLINE: This a randomized, double blind, placebo controlled, multicenter study. Patients
receive oral placebo daily for the first 4 weeks. Patients who comply with taking 80-100% of
placebo are randomized to one of two treatment arms. Arm I: Patients receive oral
eflornithine (DFMO) daily. Arm II: Patients receive an oral placebo daily. Treatment
continues for 3-5 years in the absence of unacceptable toxicity. Patients who develop skin
cancer during study undergo surgical excision and continue treatment on the arm to which
they were originally randomized. Patients are followed every 6 months through year 5.

PROJECTED ACCRUAL: A total of 334 patients (167 per arm) will be accrued for this study over
2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven previously treated stage 0, I, or II basal
or squamous cell skin cancer

PATIENT CHARACTERISTICS: Age: 21 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3
Hemoglobin at least 11.0 g/dL Hepatic: Bilirubin no greater than 2 mg/dL SGOT less than 3
times normal Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception No significant clinical
hearing loss or use of hearing aid No family history of early retinal blindness or
ornithine diaminotransferase deficiency

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplant No concurrent
tamoxifen for cancer treatment or prophylaxis Chemotherapy: Greater than 4 weeks since
prior chemotherapy No concurrent cytotoxic chemotherapy Endocrine therapy: Greater than 4
weeks since prior hormonal therapy for cancer No concurrent prednisone No concurrent
hormonal therapy for cancer treatment or prophylaxis Radiotherapy: Greater than 4 weeks
since prior radiotherapy Surgery: Greater than 4 weeks since prior major surgery No prior
solid organ transplant Other: At least 4 weeks since prior topical medications (e.g.,
tretinoin, isotretinoin, psoralen ultraviolet light therapy, or fluorouracil) for skin
cancer No concurrent antiseizure medication

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

Paul P. Carbone, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000067928

NCT ID:

NCT00005884

Start Date:

Completion Date:

Related Keywords:

  • Non-melanomatous Skin Cancer
  • basal cell carcinoma of the skin
  • squamous cell carcinoma of the skin
  • Skin Neoplasms

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