NCT00423397

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Last Updated

December 19, 2013

Status Verified

March 1, 2008

Enrollment Period

1.3 years

First QC Date

January 16, 2007

Last Update Submit

December 18, 2013

Conditions

Non-melanomatous Skin Cancer

Keywords

squamous cell carcinoma of the skinrecurrent skin cancer

Outcome Measures

Primary Outcomes (5)

  • 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

Interventions

PEG-interferon alfa-2aBIOLOGICAL
gefitinibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

peginterferon alfa-2aGefitinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • William L. Read, MD

    University of California, San Diego

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2007

First Posted

January 18, 2007

Study Start

September 1, 2006

Primary Completion

January 1, 2008

Last Updated

December 19, 2013

Record last verified: 2008-03

Locations

US(1)