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A Phase 2 Study Of BAY 43-9006 In Combination With Interferon Alfa-2b In Metastatic Renal Cell Cancer

Phase 2
18 Years
Open (Enrolling)
Clear Cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

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Trial Information

A Phase 2 Study Of BAY 43-9006 In Combination With Interferon Alfa-2b In Metastatic Renal Cell Cancer


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 rate (complete response and partial response) in patients treated
with this regimen.


I. Determine the progression-free survival and response duration of patients treated with
this regimen.

II. Correlate changes in laboratory parameters with response in patients treated with this

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily and interferon alfa subcutaneously three times a
week for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or
unacceptable toxicity.

Patients with stable or responding disease are followed every 3 months for 2 years, every 6
months for 2 years, and then annually for 1 year or until disease progression.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 10 months.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (CR+PR) using RECIST criteria

Outcome Description:

CR+PR rate will be calculated with exact 90% confidence intervals.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Daniel George

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

Related Keywords:

  • Clear Cell Renal Cell Carcinoma
  • Papillary Renal Cell Carcinoma
  • Recurrent Renal Cell Cancer
  • Stage III Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma
  • Carcinoma, Renal Cell



Duke University Medical Center Durham, North Carolina  27710