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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-melanomatous Skin Cancer

Intervention: PEG-interferon alfa-2a (Biological); gefitinib (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: University of California, San Diego

Official(s) and/or principal investigator(s):
William L. Read, MD, Study Chair, Affiliation: University of California, San Diego

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.

Clinical Details

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 design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Tolerability

Response rate to treatment with gefitinib alone for 1 month

Response rate to treatment with gefitinib in combination with PEG-interferon alfa-2a

Toxicity

Quantification of rash after treatment with gefitinib for 1 month and after the addition of PEG-interferon alfa-2a to gefitinib

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

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

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: September 2006
Last updated: December 18, 2013

Page last updated: August 23, 2015

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