Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer

This study has been completed.
Information provided by (Responsible Party):
California Cancer Consortium Identifier:
First received: April 25, 2007
Last updated: September 10, 2013
Last verified: September 2013

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
Biological: PEG-interferon alfa-2b
Drug: gefitinib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of ZD1839 (IRESSA®) and Pegylated Interferon Alfa 2b (PEG-Intron™) in Unresectable or Metastatic Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by California Cancer Consortium:

Primary Outcome Measures:
  • Progression-free status at 6 months [ Time Frame: at end of study ] [ Designated as safety issue: No ]

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

Enrollment: 21
Study Start Date: September 2004
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: PEG-interferon alfa-2b
    PEG-Interferon will be administered subcutaneously (sq) once weekly for 6 weeks
    Drug: gefitinib
    ZD1839 will be administered at a dose of 250 mg orally once daily,
Detailed Description:



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


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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 identifier: NCT00467077

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

Additional Information:
No publications provided by California Cancer Consortium

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: California Cancer Consortium Identifier: NCT00467077     History of Changes
Other Study ID Numbers: CDR0000540598, P30CA093373, CCC-PHII-40, ZENECA-AZ1839US/0227, UCD-200412338-4, UCD-ZD1839
Study First Received: April 25, 2007
Last Updated: September 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by California Cancer Consortium:
recurrent renal cell cancer
stage IV renal cell cancer
stage III renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon Alfa-2a
Interferon Alfa-2b
Peginterferon alfa-2b
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 processed this record on April 15, 2014