Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of California, San Diego
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00423397
First received: January 16, 2007
Last updated: February 6, 2009
Last verified: March 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Non-Melanomatous Skin Cancer |
Biological: PEG-interferon alfa-2a Drug: gefitinib |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Tolerability [ Designated as safety issue: Yes ]
- Response rate to treatment with gefitinib alone for 1 month [ Designated as safety issue: No ]
- Response rate to treatment with gefitinib in combination with PEG-interferon alfa-2a [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Quantification of rash after treatment with gefitinib for 1 month and after the addition of PEG-interferon alfa-2a to gefitinib [ Designated as safety issue: No ]
| Estimated Enrollment: | 16 |
| Study Start Date: | September 2006 |
| Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423397
Locations
| United States, California | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
Sponsors and Collaborators
University of California, San Diego
Investigators
| Study Chair: | William L. Read, MD | University of California, San Diego |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00423397 History of Changes |
| Other Study ID Numbers: | CDR0000521454, UCSD-051205, ZENECA-IRUSIRES0488 |
| Study First Received: | January 16, 2007 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
squamous cell carcinoma of the skin recurrent skin cancer |
Additional relevant MeSH terms:
|
Skin Neoplasms Carcinoma, Squamous Cell Neoplasms by Site Neoplasms Skin Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Squamous Cell Interferon-alpha Interferon Alfa-2a Interferons Peginterferon alfa-2a Gefitinib |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013