Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer
This trial is active, not recruiting.
|Condition||non-melanomatous skin cancer|
|Treatments||peg-interferon alfa-2a, gefitinib|
|Phase||phase 1/phase 2|
|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|
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.
Response rate to treatment with gefitinib alone for 1 month
Response rate to treatment with gefitinib in combination with PEG-interferon alfa-2a
Quantification of rash after treatment with gefitinib for 1 month and after the addition of PEG-interferon alfa-2a to gefitinib
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
|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.|
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