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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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Non-Melanomatous Skin Cancer

Thank you

Trial Information

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


- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Safety Issue:


Principal Investigator

William L. Read, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Diego


United States: Federal Government

Study ID:




Start Date:

September 2006

Completion Date:

Related Keywords:

  • Non-melanomatous Skin Cancer
  • squamous cell carcinoma of the skin
  • recurrent skin cancer
  • Skin Neoplasms
  • Carcinoma, Squamous Cell



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