Sorafenib and Interferon Alfa in Treating Patients With Metastatic or Unresectable Kidney Cancer - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00101114

Purpose

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer. Sorafenib may help interferon alfa work better by making tumor cells more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving sorafenib with interferon alfa works in treating patients with metastatic or unresectable kidney cancer.

Condition	Intervention	Phase
Kidney Cancer	Biological: recombinant interferon alfa Drug: sorafenib tosylate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of the RAF-Kinase Inhibitor BAY 43-9006 (NSC0724772, IND 69,896) in Combination With Interferon-α2B in Patients With Advanced Renal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Interferon alfa-2a Sorafenib Interferon alfa-n1 Sorafenib tosylate Interferons

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

September 2004

Detailed Description:

OBJECTIVES:

Primary

Determine the response (confirmed complete and partial response) in patients with metastatic or unresectable renal cell cancer treated with sorafenib and interferon alfa.

Secondary

Determine the probability of treatment failure at 6 months in patients treated with this regimen.
Determine the median overall survival of patients treated with this regimen.
Determine the qualitative and quantitative toxic effects of this regimen in these patients.
Correlate, preliminarily, tumor response with measures of increased signaling through the Ras-Raf pathway (p-MAPK, p-JNK, p-p38, and p-AKT) and von Hippel-Lindau gene status in patients treated with this regimen.
Correlate changes in levels of interleukin-6 and tumor markers of hypoxia, including PAI-1, VEGF, and osteopontin, with clinical outcomes in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28 and interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 8-9 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed renal cell cancer (RCC)
- Metastatic (M1) or unresectable (M0) disease
- Must have a component of clear cell RCC
  - Patients with any of the following are not eligible:
    - True papillary RCC
    - Sarcomatoid features without any clear cell component
    - Chromophobe
    - Oncocytoma
    - Collecting duct tumors
    - Transitional cell carcinoma
Measurable disease
- Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease
No prior or current brain metastases
- Patients with clinical suspicion of brain metastases must have a negative brain CT scan or MRI AND have no new symptoms of brain metastases since radiographic evaluation

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Bilirubin normal
SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)

Renal

Creatinine normal (≤ 2 times ULN for patients who have undergone prior nephrectomy) OR
Creatinine clearance ≥ 60 mL/min

Other

Not pregnant or nursing
Fertile patients must use effective contraception
Able to swallow oral medication intact
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer that is in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior interferon, interleukin-2, or other biologic response modifiers for RCC
No prior antiangiogenic therapy for RCC

Chemotherapy

No prior chemotherapy for RCC

Endocrine therapy

No prior hormonal therapy for RCC
Prior thyroid medications allowed
No concurrent systemic corticosteroid therapy
- Concurrent topical and/or inhaled steroids allowed

Radiotherapy

See Disease Characteristics
At least 4 weeks since prior radiotherapy and recovered
No prior radiotherapy to ≥ 25% of bone marrow

Surgery

At least 4 weeks since prior surgery and recovered
Prior resection of the primary tumor in patients with metastatic disease allowed

Other

No prior experimental systemic therapy for RCC
No other prior systemic therapy for RCC
No concurrent inhibitors of CYP3A4 enzyme, including any of the following:
- Ketoconazole
- Itraconazole
- Ritonavir
- Grapefruit juice
- Cyclosporine
- Carbamazepine
- Phenytoin
- Phenobarbital

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101114

Hide Study Locations

Locations

United States, California
Shasta Regional Medical Center
Redding, California, United States, 96001-0853
United States, Illinois
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
United States, Indiana
St. Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
United States, Kansas
Associates in Womens Health
Wichita, Kansas, United States, 67203
Cancer Center at Stormont-Vail Regional Health Center
Topeka, Kansas, United States, 66606
Cancer Center of Kansas - Arkansas City
Arkansas City, Kansas, United States, 67005
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
Cancer Center of Kansas - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas - Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States, 67214-3728
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, P.A.
Wichita, Kansas, United States, 67208
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Pratt Cancer Center of Kansas
Pratt, Kansas, United States, 67124
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States, 66606
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Missouri
St. Francis Medical Center
Cape Girardeau, Missouri, United States, 63701
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Cape Girardeau, Missouri, United States, 63701
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804-2263
United States, Montana
Benefis Healthcare Hospital
Great Falls, Montana, United States, 59405
Big Sky Oncology
Great Falls, Montana, United States, 59405
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, New York
Adirondack Cancer Care
Glens Falls, New York, United States, 12801
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
CCOP - Dayton
Dayton, Ohio, United States, 45429
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Middletown Regional Hospital
Middletown, Ohio, United States, 45044-4898
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-9001
Community Oncology Group - Independence
Independence, Ohio, United States, 44131
Good Samaritan Hospital
Dayton, Ohio, United States, 45406-1891
Grandview Hospital
Dayton, Ohio, United States, 45405
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428-1002
United States, Washington
Cancer Care Center at Skagit Valley Hospital
Mount Vernon, Washington, United States, 98273
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Central Washington Hospital
Wenatchee, Washington, United States, 98801
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Wenatchee Valley Clinic
Wenatchee, Washington, United States, 98801
Harborview Medical Center
Seattle, Washington, United States, 98104
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States, 98225-1898
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98104
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Group Health Central Hospital
Seattle, Washington, United States, 98112

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Investigator:	Christopher W. Ryan, MD	OHSU Knight Cancer Institute
Investigator:	Tomasz M. Beer, MD	OHSU Knight Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Goldman BH, Lara PN, Beer TM, et al.: Clinical and molecular factors predictive of outcome with first-line sorafenib-based therapy in advanced renal carcinoma (RCC): an analysis of SWOG 0412. [Abstract] J Clin Oncol 25 (Suppl 18): A-5108, 261s, 2007.

Ryan CW, Goldman BH, Lara PN Jr, Mack PC, Beer TM, Tangen CM, Lemmon D, Pan CX, Drabkin HA, Crawford ED; Southwest Oncology Group. Sorafenib with interferon alfa-2b as first-line treatment of advanced renal carcinoma: a phase II study of the Southwest Oncology Group. J Clin Oncol. 2007 Aug 1;25(22):3296-301.

Study ID Numbers:	CDR0000405893, SWOG-S0412
Study First Received:	January 7, 2005
Last Updated:	April 4, 2009
ClinicalTrials.gov Identifier:	NCT00101114 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III renal cell cancer
stage IV renal cell cancer
clear cell renal cell carcinoma
recurrent renal cell cancer

Additional relevant MeSH terms:

Anti-Infective Agents
Interferon Type I, Recombinant
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Protein Kinase Inhibitors
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Growth Inhibitors
Kidney Diseases

Angiogenesis Modulating Agents
Interferon-alpha
Neoplasms by Histologic Type
Growth Substances
Interferons
Enzyme Inhibitors
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Carcinoma, Renal Cell
Adenocarcinoma
Interferon Alfa-2a
Sorafenib

ClinicalTrials.gov processed this record on November 27, 2009