Overview

This trial is active, not recruiting.

Condition non-melanomatous skin cancer
Treatments peg-interferon alfa-2a, gefitinib
Phase phase 1/phase 2
Target EGFR
Sponsor University of California, San Diego
Collaborator National Cancer Institute (NCI)
Start date September 2006
End date January 2008
Trial size 16 participants
Trial identifier NCT00423397, CDR0000521454, UCSD-051205, ZENECA-IRUSIRES0488

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 of skin cancer. Giving gefitinib together with PEG-interferon alfa-2a may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of PEG-interferon alfa-2a when given together with gefitinib and to see how well they work in treating patients with unresectable or metastatic skin cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Tolerability
time frame:
Response rate to treatment with gefitinib alone for 1 month
time frame:
Response rate to treatment with gefitinib in combination with PEG-interferon alfa-2a
time frame:
Toxicity
time frame:
Quantification of rash after treatment with gefitinib for 1 month and after the addition of PEG-interferon alfa-2a to gefitinib
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase I/II Pilot Study of Bioimmunotherapy With IRESSA (Gefitinib) and Pegylated Interferon Alpha-2a for Patients With Unresectable/Metastatic Squamous Cell Carcinoma of the Skin
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 patients treated with gefitinib for 1 month. - Determine whether the addition of weekly PEG-interferon alfa-2a to ongoing gefitinib improves response rate in these patients . - Determine whether PEG-interferon alfa-2a exacerbates rash in patients who have been treated with gefitinib for 1 month. OUTLINE: This is a phase I, pilot, dose de-escalation study of PEG-interferon alfa-2a followed by an open-label, phase II study. - Phase I: Patients receive oral gefitinib alone once daily for 4 weeks. Beginning in week 5, patients also receive PEG-interferon alfa-2a subcutaneously once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of patients receive de-escalating doses of PEG-interferon alfa-2a until a tolerable dose is determined. - Phase II: Patients receive gefitinib and PEG-interferon alfa-2a at the tolerable dose determined in phase I. PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).