Status:
TERMINATED
Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Clear Cell Renal Cell Carcinoma
Papillary Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth or by blocking blood flow to the tumor. Interferon alfa may interfere with the growth of tumor cell...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the feasibility and tolerability of sorafenib and interferon alfa in patients with locally advanced or metastatic renal cell carcinoma. II. Determine the response ra...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed renal cell carcinoma
- Locally advanced or metastatic disease
- All histologic subtypes allowed
- Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- No known brain metastases or leptomeningeal disease
- Performance status - ECOG 0-2
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- No bleeding diathesis
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance ≥ 60 mL/min
- No uncontrolled hypertension
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of sensitivity to E. coli-derived products
- No history of severe depression
- No active infection requiring antibiotics
- No seizure disorder requiring antiepileptic medication
- No medical condition likely to require systemic corticosteroids
- No autoimmune disorder that could result in life-threatening complications
- No other uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
- No more than 1 prior biologic response modifier regimen
- At least 4 weeks since prior biologic response modifiers
- No prior interferon alfa
- No prior chemotherapy
- At least 4 weeks since prior radiotherapy to non-index lesions
- Prior radiotherapy to index lesion allowed provided irradiated lesion progressed ≥ 20% in diameter
- At least 2 weeks since prior major surgery
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent therapeutic anticoagulation therapy
- Concurrent prophylactic anticoagulation, such as low-dose warfarin, for venous or arterial access device allowed provided PT, PTT, and INR are normal
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00098618
Start Date
October 1 2004
Last Update
July 2 2013
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710