Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Non-melanomatous Skin Cancer
• Intervention / Treatment: Drug: gefitinib; Biological: PEG-interferon alfa-2a

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093-0658
      • Rebecca and John Moores UCSD Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Tolerability
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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Anticipated): January 1, 2008

Study Registration Dates

• First Submitted: January 16, 2007
• First Submitted That Met QC Criteria: January 16, 2007
• First Posted (Estimate): January 18, 2007

Study Record Updates

• Last Update Posted (Estimate): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: squamous cell carcinoma of the skin; recurrent skin cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Protein Kinase Inhibitors; Interferons; Interferon-alpha; Peginterferon alfa-2a; Interferon alpha-2; Gefitinib
• Other Study ID Numbers: CDR0000521454; UCSD-051205; ZENECA-IRUSIRES0488