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