Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Clear Cell Renal Cell Carcinoma Papillary Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage III Renal Cell Cancer Stage IV Renal Cell Cancer |
Drug: sorafenib tosylate Biological: recombinant interferon alfa Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study Of BAY 43-9006 In Combination With Interferon Alfa-2b In Metastatic Renal Cell Cancer |
- Overall response rate (CR+PR) using RECIST criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]CR+PR rate will be calculated with exact 90% confidence intervals.
- Grade 3+ toxicities assessed using NCI CTCAE version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]Toxicities will be tabulated by type and grade. Toxicity rates will be calculated with exact 90% confidence intervals.
- Progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Kaplan-Meier curves will be used.
- Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Kaplan-Meier curves will be used.
- Duration of response [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented , assessed up to 5 years ] [ Designated as safety issue: No ]Kaplan-Meier curves will be used.
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2004 |
| Estimated Primary Completion Date: | January 2100 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (sorafenib tosylate and recombinant interferon alfa)
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
|
Drug: sorafenib tosylate
Given orally
Other Names:
Biological: recombinant interferon alfa
Given orally
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00098618 History of Changes |
| Other Study ID Numbers: | NCI-2012-02638, DUMC-6258-04-9R0, U01CA099118, CDR0000398171 |
| Study First Received: | December 7, 2004 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Interferon-alpha Interferon Alfa-2a Interferons |
Sorafenib Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013