Status:
TERMINATED
Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
Lead Sponsor:
California Cancer Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00467077
Start Date
September 1 2004
End Date
March 1 2011
Last Update
March 17 2017
Active Locations (3)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
2
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
3
University of California Davis Cancer Center
Sacramento, California, United States, 95817