Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-melanomatous Skin Cancer
Intervention: PEG-interferon alfa-2a (Biological); gefitinib (Drug)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: University of California, San Diego Official(s) and/or principal investigator(s): William L. Read, MD, Study Chair, Affiliation: University of California, San Diego
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.
Clinical Details
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 design: Masking: Open Label, Primary Purpose: Treatment
Primary outcome: TolerabilityResponse 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
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Rebecca and John Moores UCSD Cancer Center, La Jolla, California 92093-0658, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: September 2006
Last updated: December 18, 2013
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