NCT00098618

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

December 7, 2004

Last Update Submit

July 1, 2013

Conditions

Clear Cell Renal Cell CarcinomaPapillary Renal Cell CarcinomaRecurrent Renal Cell CancerStage III Renal Cell CancerStage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (5)

  • Overall response rate (CR+PR) using RECIST criteria

    CR+PR rate will be calculated with exact 90% confidence intervals.

    Up to 5 years

  • 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.

    Up to 5 years

  • Progression-free survival

    Kaplan-Meier curves will be used.

    Up to 5 years

  • Overall survival

    Kaplan-Meier curves will be used.

    Up to 5 years

  • Duration of response

    Kaplan-Meier curves will be used.

    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

Study Arms (1)

Treatment (sorafenib tosylate and recombinant interferon alfa)

EXPERIMENTAL

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 tosylateBiological: recombinant interferon alfaOther: laboratory biomarker analysis

Interventions

sorafenib tosylateDRUG

Given orally

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Treatment (sorafenib tosylate and recombinant interferon alfa)
recombinant interferon alfaBIOLOGICAL

Given orally

Also known as: Alferon N, alpha interferon, IFN-A, Intron A, Roferon-A
Treatment (sorafenib tosylate and recombinant interferon alfa)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (sorafenib tosylate and recombinant interferon alfa)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

SorafenibInterferon-alphaInterferon Alfa-n3IntronsInterferon alpha-2

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsDNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenes

Study Officials

  • Daniel George

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2004

First Posted

December 8, 2004

Study Start

October 1, 2004

Primary Completion

January 1, 2006

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

US(1)