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Phase II Trial of ZD1839 (IRESSA®) and Pegylated Interferon Alfa 2b (PEG-Intron™) in Unresectable or Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Kidney Cancer

Thank you

Trial Information

Phase II Trial of ZD1839 (IRESSA®) and Pegylated Interferon Alfa 2b (PEG-Intron™) in Unresectable or Metastatic Renal Cell Carcinoma



- 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

- 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

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.

Inclusion Criteria


- 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

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free status at 6 months

Outcome Time Frame:

at end of study

Safety Issue:


Principal Investigator

Primo N. Lara, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis


United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

March 2011

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • stage III renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
University of California Davis Cancer Center Sacramento, California  95817
City of Hope Comprehensive Cancer Center Duarte, California  91010