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A Phase II/III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Of Celecoxib In Subjects With Actinic Keratoses


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Precancerous Condition

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Trial Information

A Phase II/III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Of Celecoxib In Subjects With Actinic Keratoses


OBJECTIVES:

- Compare celecoxib vs placebo in terms of preventing the development of new actinic
keratoses in patients with actinic keratoses.

- Compare these treatment regimens in terms of inducing regression of actinic keratoses
in these patients.

- Determine the safety of this drug in these patients.

- Compare the effect of these treatment regimens on potential surrogate end-point
biomarkers in areas of actinic keratosis, sun-exposed skin, and non-sun-exposed skin
and correlate these biomarkers with clinical outcome in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral celecoxib twice daily for 9 months in the absence of
disease progression or unacceptable toxicity.

- Arm II: Patients receive oral placebo as in arm I. Patients are followed at 2 months
after completing treatment.

PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of Fitzpatrick skin types I, II, or III

- Sun-damaged skin with 10-40 actinic keratoses on the upper extremities (upper arms,
forearms, and hands), neck, face, and scalp combined

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 125,000/mm^3

- Hemoglobin at least lower limit of normal

- No significant bleeding disorder

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 1.5 times ULN

- No chronic or acute hepatic disorder

Renal:

- Creatinine no greater than 1.5 times ULN

- BUN no greater than 1.5 times ULN

- No chronic or acute renal disorder

Gastrointestinal:

- No history of or active inflammatory bowel disease

- No active pancreatitis

- Not diagnosed with esophageal, gastric, pyloric channel, or duodenal ulceration
within the past 30 days

Other:

- No history of keloid formation

- No known photosensitivity disorder

- No history of hypersensitivity or adverse reaction to sulfonamides, COX-2 inhibitors,
salicylates, or other NSAIDs

- No other condition that would preclude study

- No other medical or psychosocial condition that would preclude study

- No other malignancy within the past 5 years except:

- Carcinoma in situ of the cervix

- Curatively excised nonmelanoma skin cancer

- Stage 0 chronic lymphocytic leukemia

- Any cancer for which the patient is currently without evidence of disease, has
not been treated for tumor within the past 6 months, has no current or planned
therapy, and has an expected disease-free survival of at least 5 years

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 30 days since prior systemic immunotherapy

- No concurrent immunotherapy

Chemotherapy:

- At least 3 months since prior topical fluorouracil (5-FU)

- At least 6 months since other prior topical chemotherapy

- No concurrent topical chemotherapy, including 5-FU

- No other concurrent chemotherapy

Endocrine therapy:

- At least 6 months since prior oral or IV corticosteroids for more than 2 consecutive
weeks

- At least 6 months since prior inhaled or nasal corticosteroids for more than 4 weeks
duration

- At least 14 days since prior topical corticosteroids

- At least 30 days since prior nasal corticosteroids (except mometasone)

- No concurrent oral or IV corticosteroids for more than 2 consecutive weeks during any
6 month period during study

- No concurrent inhaled or nasal steroids (except mometasone) for more than 4 weeks
during any 6 month period during study

- No concurrent hormonal or steroidal therapy, including topical corticosteroids

- Concurrent hormone replacement therapy (e.g., estrogen or thyroid hormone
replacement) allowed

Radiotherapy:

- At least 6 months since prior local radiotherapy to areas being studied

- At least 30 days since other prior radiotherapy

- No concurrent radiotherapy, including local radiotherapy to areas being studied

Surgery:

- Not specified

Other:

- At least 30 days since prior cryotherapy to target lesions

- At least 60 days since prior laser resurfacing, dermabrasion, or chemical peels

- At least 30 days since prior investigational medication

- At least 14 days since prior topical alphahydroxyacids (e.g., glycolic acid or lactic
acid) or retinoids

- At least 30 days since prior systemic psoralens or retinoids

- At least 30 days since prior treatment for esophageal, gastric, pyloric channel, or
duodenal ulcers

- At least 30 days since prior aspirin (more than 100 mg/day), other nonsteroidal
anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors at a frequency of at least 3
times per week for more than 2 weeks (except cardioprotective doses of aspirin (no
more than 100 mg/day)

- No concurrent systemic psoralens or retinoids

- No concurrent prescription or over-the-counter topical medications to areas being
studied (e.g., vitamin A derivatives)

- No concurrent cryotherapy to target lesions

- No concurrent laser resurfacing, dermabrasion, or chemical peels

- No other concurrent investigational medications

- No concurrent fluconazole or lithium

- No concurrent chronic NSAIDs or COX-2 inhibitors (at least 3 times per week for more
than 2 consecutive weeks per year)

- Concurrent cardioprotective doses of oral aspirin (100 mg per day or less) allowed

- Concurrent moisturizer/emollient or sunscreen allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Principal Investigator

Craig A. Elmets, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000069099

NCT ID:

NCT00027976

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Precancerous Condition
  • actinic keratosis
  • Keratosis
  • Keratosis, Actinic
  • Precancerous Conditions

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642