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

NCT ID: NCT00423397

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-melanomatous Skin Cancer

Keywords

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squamous cell carcinoma of the skin recurrent skin cancer

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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PEG-interferon alfa-2a

Intervention Type BIOLOGICAL

gefitinib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Principal Investigators

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William L. Read, MD

Role: STUDY_CHAIR

University of California, San Diego

Locations

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Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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UCSD-051205

Identifier Type: -

Identifier Source: secondary_id

ZENECA-IRUSIRES0488

Identifier Type: -

Identifier Source: secondary_id

CDR0000521454

Identifier Type: -

Identifier Source: org_study_id