Status:
UNKNOWN
Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Non-melanomatous Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PEG-interferon alfa-2a may interfere with the growth of tumor cells and slow the growth ...
Detailed Description
OBJECTIVES: * Determine the tolerability of gefitinib and PEG-interferon alfa-2a in patients with unresectable or metastatic squamous cell carcinoma of the skin. * Determine the response rate in pati...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed primary squamous cell carcinoma of the skin
- Metastatic and/or unresectable locally recurrent disease
- Measurable disease
- No curative treatment option (including resection and radiotherapy) exists or is unacceptably morbid
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Absolute neutrophil count \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Bilirubin \< 1.5 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV/AIDS allowed
- Patients with other cancer diagnoses (e.g., chronic lymphocytic leukemia) are eligible provided disease is controlled and does not require active treatment
- No pre-existing medical problems or laboratory abnormalities ≥ grade 3 except renal allograft patients with chronic, stable grade 3-4 renal insufficiency who are dialysis candidates
- Nontransplant patients with any degree of renal insufficiency allowed
- No serious medical or psychiatric illness that would preclude study compliance
- No evidence of severe or uncontrolled (≥ grade 3) systemic disease (e.g., unstable or uncompensated respiratory, cardiac, or hepatic disease)
- PRIOR CONCURRENT THERAPY:
- Prior solid organ transplant allowed
- Prior cytotoxic chemotherapy and radiotherapy allowed
- More than 30 days since prior experimental cancer treatment
- No prior epidermal growth factor receptor-inhibiting drugs, including gefitinib, erlotinib hydrochloride, or cetuximab
- No concurrent radiotherapy
- No concurrent cytotoxic chemotherapy or other drugs intended to control skin cancer
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00423397
Start Date
September 1 2006
Last Update
December 19 2013
Active Locations (1)
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1
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658