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Sorafenib With or Without Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00126594
  Purpose

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with interferon alfa-2b may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well they work compared to sorafenib alone in treating patients with metastatic kidney cancer.


Condition Intervention Phase
Kidney Cancer
Drug: recombinant interferon alfa
Drug: sorafenib tosylate
Procedure: gene expression analysis
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Sorafenib Sorafenib tosylate Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A Phase II Clinical Trial to Evaluate the Efficacy of BAY 43-9006 With or Without Low Dose Interferon in Metastatic Renal Cell Carcinoma

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

Primary Outcome Measures:
  • Objective response rate (complete response and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Correlation of objective response rate [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2005
Detailed Description:

OBJECTIVES:

Primary

  • Compare the efficacy of sorafenib with vs without low-dose interferon alfa-2b, in terms of response rate, in patients with metastatic renal cell carcinoma.
  • Compare the toxic effects of these regimens in these patients.

Secondary

  • Compare the progression-free and overall survival of patients treated with these regimens.
  • Compare the duration of response in patients treated with these regimens.
  • Evaluate the single nucleotide polymorphisms (SNP) patterns in tissue specimens from these patients.

OUTLINE: This is a randomized study. Patients are stratified according to ECOG performance status (0 vs 1), presence of anemia (no vs hemoglobin < 14 g/dL for males OR hemoglobin < 12 g/dL for females), prior nephrectomy (no vs yes), and lactic dehydrogenase (LDH) level (LDH ≤ 1.5 times upper limit of normal (ULN) vs LDH > 1.5 times ULN). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral sorafenib twice daily on days 1-28.
  • Arm II: Patients receive sorafenib as in arm I and low-dose interferon alfa-2b subcutaneously twice daily on days 1-28.

In both arms, courses repeat every 28 days in the absence of progressive disease or unacceptable toxicity.

Tissue samples are analyzed for single nucleotide polymorphisms (SNP) patterns via genotyping.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically and cytologically confirmed renal cell carcinoma

    • Clear cell histology
    • Metastatic disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No primary brain tumor, brain metastases, or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin > 9.0 g/dL (transfusion or epoetin alfa [e.g., Epogen^®] support allowed)
  • No clinical history of coagulopathy
  • No bleeding diathesis or thrombosis

Hepatic

  • Bilirubin ≤ 2.0 mg/dL
  • AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)
  • Albumin > 3.0 g/dL

Renal

  • Creatinine ≤ 2.0 mg/dL

Cardiovascular

  • Must not have any of the following cardiovascular conditions:

    • Uncontrolled hypertension
    • History of stroke
    • Clinically significant cardiovascular disease
    • Myocardial infarction within the past year
    • Unstable angina
    • New York Heart Association class II-IV congestive heart failure
    • Serious cardiac dysrhythmia refractory to medical treatment
    • Peripheral vascular disease ≥ grade 2

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to swallow pills
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of any site
  • No active acute infection
  • No history of disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study participation
  • No uncontrolled seizure disorder
  • No history of severe depression

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 4 weeks since prior radiotherapy for renal cell carcinoma and recovered

Surgery

  • Not specified

Other

  • Recovered from all adverse events due to agents administered > 4 weeks prior to study entry
  • No prior systemic anticancer therapy for renal cell carcinoma
  • No other concurrent experimental drugs
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent rifampin or Hypericum perforatum (St. John's wort)
  • No concurrent cytochrome p450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
  • No concurrent therapeutic anticoagulation therapy

    • Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) of venous access devices allowed provided INR ≥ 1.5 is due to warfarin therapy
  • Concurrent bisphosphonates allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126594

Locations
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Eric Jonasch, MD M.D. Anderson Cancer Center
Investigator: Christopher Logothetis, MD M.D. Anderson Cancer Center
Investigator: Qi Liu, MD, PhD M.D. Anderson Cancer Center
  More Information

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

Study ID Numbers: CDR0000437796, MDA-2004-0526, NCI-6629
Study First Received: August 2, 2005
Last Updated: December 31, 2008
ClinicalTrials.gov Identifier: NCT00126594  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
clear cell renal cell carcinoma
stage IV renal cell cancer

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Interferons
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Interferon Alfa-2a
Adenocarcinoma
Clear cell renal cell carcinoma
Sorafenib
Interferon Alfa-2b
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009