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

Non-melanomatous Skin Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00423397
• Other study ID #: CDR0000521454
• Secondary ID: UCSD-051205ZENEC
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: January 16, 2007
• Last updated: December 18, 2013
• Start date: September 2006

Study information

• Verified date: March 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Non-melanomatous Skin Cancer
• Skin Neoplasms

Intervention

Biological:
• PEG-interferon alfa-2a

Drug:
• gefitinib

Locations

Country	Name	City	State
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability			Yes
Primary	Response rate to treatment with gefitinib alone for 1 month			No
Primary	Response rate to treatment with gefitinib in combination with PEG-interferon alfa-2a			No
Primary	Toxicity			Yes
Primary	Quantification of rash after treatment with gefitinib for 1 month and after the addition of PEG-interferon alfa-2a to gefitinib			No