search
Back to results

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

Primary Purpose

Clear Cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Recurrent Renal Cell Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sorafenib tosylate
recombinant interferon alfa
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (sorafenib tosylate and recombinant interferon alfa)

Arm Description

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

Outcomes

Primary Outcome Measures

Overall response rate (CR+PR) using RECIST criteria
CR+PR rate will be calculated with exact 90% confidence intervals.
Grade 3+ toxicities assessed using NCI CTCAE version 3.0
Toxicities will be tabulated by type and grade. Toxicity rates will be calculated with exact 90% confidence intervals.
Progression-free survival
Kaplan-Meier curves will be used.
Overall survival
Kaplan-Meier curves will be used.
Duration of response
Kaplan-Meier curves will be used.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2004
Last Updated
July 1, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00098618
Brief Title
Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
Official Title
A Phase 2 Study Of BAY 43-9006 In Combination With Interferon Alfa-2b In Metastatic Renal Cell Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Study Start Date
October 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clear Cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (sorafenib tosylate and recombinant interferon alfa)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Other Intervention Name(s)
BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Intervention Description
Given orally
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Other Intervention Name(s)
Alferon N, alpha interferon, IFN-A, Intron A, Roferon-A
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Overall response rate (CR+PR) using RECIST criteria
Description
CR+PR rate will be calculated with exact 90% confidence intervals.
Time Frame
Up to 5 years
Title
Grade 3+ toxicities assessed using NCI CTCAE version 3.0
Description
Toxicities will be tabulated by type and grade. Toxicity rates will be calculated with exact 90% confidence intervals.
Time Frame
Up to 5 years
Title
Progression-free survival
Description
Kaplan-Meier curves will be used.
Time Frame
Up to 5 years
Title
Overall survival
Description
Kaplan-Meier curves will be used.
Time Frame
Up to 5 years
Title
Duration of response
Description
Kaplan-Meier curves will be used.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel George
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs