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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00423397
Recruitment Status : Unknown
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2007
Last Update Posted : December 19, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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 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.

Condition or disease Intervention/treatment Phase
Non-melanomatous Skin Cancer Biological: PEG-interferon alfa-2a Drug: gefitinib Phase 1 Phase 2

Detailed Description:


  • 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  (Clinical Trial)
Estimated Enrollment : 16 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2006
Estimated Primary Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Tolerability
  2. Response rate to treatment with gefitinib alone for 1 month
  3. Response rate to treatment with gefitinib in combination with PEG-interferon alfa-2a
  4. Toxicity
  5. Quantification of rash after treatment with gefitinib for 1 month and after the addition of PEG-interferon alfa-2a to gefitinib

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00423397

United States, California
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Sponsors and Collaborators
University of California, San Diego
National Cancer Institute (NCI)
Study Chair: William L. Read, MD University of California, San Diego Identifier: NCT00423397     History of Changes
Other Study ID Numbers: CDR0000521454
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: March 2008

Keywords provided by National Cancer Institute (NCI):
squamous cell carcinoma of the skin
recurrent skin cancer

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Skin Diseases
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action