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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
California Cancer Consortium
ClinicalTrials.gov Identifier:
NCT00467077
First received: April 25, 2007
Last updated: September 10, 2013
Last verified: September 2013
  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
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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: California Cancer Consortium
ClinicalTrials.gov 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
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Peginterferon alfa-2b
Reaferon
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

ClinicalTrials.gov processed this record on July 29, 2014