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

NCT ID: NCT00467077

Last Updated: 2017-03-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2011-03-31

Brief Summary

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.

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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gefitinib and PEG-IFNa Treatment

Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).

Group Type: EXPERIMENTAL

PEG-interferon alfa-2b

Intervention Type: BIOLOGICAL

PEG-Interferon will be administered subcutaneously (sq) once weekly for 6 weeks

gefitinib

Intervention Type: DRUG

ZD1839 will be administered at a dose of 250 mg orally once daily,

Interventions

PEG-interferon alfa-2b

PEG-Interferon will be administered subcutaneously (sq) once weekly for 6 weeks

Intervention Type: BIOLOGICAL

gefitinib

ZD1839 will be administered at a dose of 250 mg orally once daily,

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

California Cancer Consortium

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Primo N. Lara, MD

Role: STUDY_CHAIR

University of California, Davis

Locations

City of Hope Comprehensive Cancer Center

Duarte, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

University of California Davis Cancer Center

Sacramento, California, United States

Countries

United States

References

Shek D, Longmate J, Quinn DI, Margolin KA, Twardowski P, Gandara DR, Frankel P, Pan CX, Lara PN Jr. A phase II trial of gefitinib and pegylated IFNalpha in previously treated renal cell carcinoma. Int J Clin Oncol. 2011 Oct;16(5):494-9. doi: 10.1007/s10147-011-0212-8. Epub 2011 Mar 23.

Reference Type: DERIVED

PMID: 21431345 (View on PubMed)

Other Identifiers

P30CA093373

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCC-PHII-40

Identifier Type: -

Identifier Source: secondary_id

ZENECA-AZ1839US/0227

Identifier Type: -

Identifier Source: secondary_id

UCD-200412338-4

Identifier Type: -

Identifier Source: secondary_id

UCD-ZD1839

Identifier Type: -

Identifier Source: secondary_id

CDR0000540598

Identifier Type: -

Identifier Source: org_study_id