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

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Cancer Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gefitinib; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b

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