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Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: California Cancer Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00467077
  Purpose

RATIONALE: Gefitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PEG-interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of kidney cancer. Giving gefitinib together with PEG-interferon alfa-2b may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gefitinib together with PEG-interferon alfa-2b works in treating patients with unresectable or metastatic kidney cancer.


Condition Intervention Phase
Kidney Cancer
Drug: PEG-interferon alfa-2b
Drug: gefitinib
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: ZD1839 Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of ZD1839 (IRESSA®) and Pegylated Interferon Alfa 2b (PEG-Intron™) in Unresectable or Metastatic Renal Cell Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free status at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate as measured by RECIST criteria [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: September 2004
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the 6-month progression-free survival of patients with unresectable or metastatic renal cell carcinoma treated with gefitinib and PEG-interferon alfa-2b.

Secondary

  • Determine the response rate (by RECIST criteria), duration of response, time to treatment failure, and overall survival of patients treated with this regimen.
  • Assess toxicity and tolerability of this regimen in these patients.
  • Determine the pre-treatment expression of the von Hippel-Lindau (VHL) protein, the epidermal growth factor receptor (EGFR), and p27, and correlate with response to treatment.
  • Determine post-treatment alteration of EGFR and p27 expression in patients with tumors accessible for serial biopsy.
  • Assess changes in EGFR levels in buccal epithelial cells in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib once daily and PEG-interferon alfa-2b subcutaneously once weekly in weeks 1-6. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response or stable disease after completion of course 2 continue to receive gefitinib alone as above in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 39 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 renal cell carcinoma

    • Metastatic or advanced/unresectable disease
  • Measurable or nonmeasurable disease as defined by RECIST criteria
  • No uncontrolled brain metastases

    • Patients with adequately treated brain metastases who are not taking anticonvulsants and corticosteroids may be eligible

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 12 weeks
  • WBC ≥ 3,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Absolute granulocyte count ≥ 1,500/mm³
  • Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min
  • Bilirubin ≤ 1.5 mg/dL
  • AST ≤ 2 times upper limit of normal (ULN)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently in complete remission
  • No known severe hypersensitivity to gefitinib or its excipients
  • No incomplete healing from previous oncologic or other major surgery
  • No unresolved chronic toxicity > grade 2 from previous anticancer therapy (except alopecia and anemia)
  • No evidence of clinically active interstitial lung disease

    • Patients with chronic stable radiographic changes who are asymptomatic are eligible
  • No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • No other significant clinical disorder or laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • More than 30 days since prior nonapproved or investigational drugs
  • More than 6 weeks since prior aldesleukin or interferon and recovered
  • At least 3 weeks since prior radiotherapy
  • No prior gefitinib
  • Prior chemotherapy or biological therapy allowed
  • Prior or concurrent bisphosphonate therapy for bone metastases allowed
  • No concurrent phenytoin, carbamazepine, rifampin, barbiturates, phenobarbital, or Hypericum perforatum (St. John's wort)
  • No other concurrent agents specifically designed to inhibit the epidermal growth factor receptor (EGFR)
  • No concurrent radiotherapy to measurable lesions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467077

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Sponsors and Collaborators
California Cancer Consortium
Investigators
Study Chair: Primo N. Lara, MD University of California, Davis
Investigator: Corinne Turrell, CCRP University of California, Davis
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: University of California Davis Cancer Center ( Primo N. Lara )
Study ID Numbers: CDR0000540598, CCC-PHII-40, ZENECA-AZ1839US/0227, UCD-200412338-4, UCD-ZD1839
Study First Received: April 25, 2007
Last Updated: October 1, 2008
ClinicalTrials.gov Identifier: NCT00467077  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage IV renal cell cancer
stage III renal cell cancer

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Interferons
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Urologic Diseases
Kidney Neoplasms
Peginterferon alfa-2b
Carcinoma, Renal Cell
Kidney Diseases
Interferon Alfa-2a
Adenocarcinoma
Gefitinib
Interferon Alfa-2b
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009