Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

National Cancer Institute (NCI)

Status and phase

Terminated

Phase 2

Conditions

Recurrent Renal Cell Cancer

Stage IV Renal Cell Cancer

Clear Cell Renal Cell Carcinoma

Stage III Renal Cell Cancer

Papillary Renal Cell Carcinoma

Treatments

Drug: sorafenib tosylate

Biological: recombinant interferon alfa

Other: laboratory biomarker analysis

Study type

Interventional

Funder types

NIH

Identifiers

NCT00098618

CDR0000398171

NCI-6553

U01CA099118 (U.S. NIH Grant/Contract)

NCI-2012-02638

6258-04-9R0

Details and patient eligibility

About

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 cells and slow the growth of kidney cancer. Sorafenib may help interferon alfa kill more tumor cells by making tumor cells more sensitive to the drug. Giving sorafenib together with interferon alfa may kill more tumor cells. This phase II trial is studying how well giving sorafenib with interferon alfa works in treating patients with locally advanced or metastatic kidney cancer.

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

SECONDARY OBJECTIVES:

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 regimen.

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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