Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer
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|ClinicalTrials.gov Identifier: NCT00423397|
Recruitment Status : Unknown
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 18, 2007
Last Update Posted : December 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-melanomatous Skin Cancer||Biological: PEG-interferon alfa-2a Drug: gefitinib||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Masking:||None (Open Label)|
|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 Start Date :||September 2006|
|Estimated Primary Completion Date :||January 2008|
- Response rate to treatment with gefitinib alone for 1 month
- Response rate to treatment with gefitinib in combination with PEG-interferon alfa-2a
- Quantification of rash after treatment with gefitinib for 1 month and after the addition of PEG-interferon alfa-2a to gefitinib
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423397
|United States, California|
|Rebecca and John Moores UCSD Cancer Center|
|La Jolla, California, United States, 92093-0658|
|Study Chair:||William L. Read, MD||University of California, San Diego|