NCT00101114

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

1.7 years

First QC Date

January 7, 2005

Last Update Submit

February 27, 2013

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Response probability

    Up to 3 years

Secondary Outcomes (2)

  • Time to treatment failure

    From date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment, assessed up to 3 years

  • Survival

    Up to 3 years

Study Arms (1)

Treatment (sorafenib tosylate, interferon alpha-2b)

EXPERIMENTAL

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.

Drug: sorafenib tosylateBiological: recombinant interferon alfa-2bOther: laboratory biomarker analysis

Interventions

sorafenib tosylateDRUG

Given PO

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Treatment (sorafenib tosylate, interferon alpha-2b)
recombinant interferon alfa-2bBIOLOGICAL

Given SC

Also known as: Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B, Intron A
Treatment (sorafenib tosylate, interferon alpha-2b)
laboratory biomarker analysisOTHER

Optional correlative studies

Treatment (sorafenib tosylate, interferon alpha-2b)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have histologically or cytologically confirmed renal cell carcinoma which is either metastatic (M1) or unresectable (M0); patients must have a component of conventional clear cell renal carcinoma; patients with true papillary renal cell carcinoma, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors and transitional cell carcinoma are NOT eligible
  • Patients must have measurable disease; soft tissue disease, which has been radiated in the 2 months prior to registration, is not assessable as measurable disease; X-rays, scans, or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or physical examinations for non-measureable disease must have been completed within 42 days prior to registration; all disease must be assessed
  • Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection and have recovered from surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery
  • Patients must not have received any prior systemic therapy for renal cell carcinoma, including chemotherapy, interferon, interleukin-2, other biologic response modifiers, anti-angiogenic therapy, hormonal therapy, or any other experimental systemic therapy; prior treatment with thyroid medications is allowed
  • Patients may have received prior radiation therapy to less than 25% of the bone marrow; at least 28 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration
  • Total bilirubin =\< institutional upper limit of normal
  • SGOT or SGPT =\< 2.5 x institutional upper limit of normal
  • Serum creatinine =\< institutional upper limit of normal or calculated creatinine clearance \>= 60 mL/min for patients with creatinine levels above institutional normal
  • Patients who have had a prior nephrectomy must have a serum creatinine =\< 2 x institutional upper limit of normal
  • Patients must be offered the opportunity to consent for specimen submission
  • Patients must have a Zubrod performance status of 0-1
  • Patients with a history of brain metastases or who currently have treated to untreated brain metastases are not eligible; patients with clinical suspicion of brain metastases must have a brain CT or MRI negative for metastatic disease obtained within 56 days prior to registration and must not have any new symptoms since radiographic evaluation was done
  • Any ongoing requirement for systemic corticosteroid therapy is not permitted; topical and/or inhaled steroids are allowed
  • Patients must not be on drugs known to be potent inhibitors of the CYP 3A4 enzyme as BAY 43-9006 is at least partially metabolized by this enzyme in the liver; the possible effect that inhibitors of this enzyme may have on the metabolism of BAY 43-9006 is unknown; therefore, patients who are on the following drugs are not eligible (patients should not take these drugs while receiving protocol treatment): ketoconazole, itraconazole, ritonavir, products containing grapefruit juice, cyclosporine, carbamazepine, phenytoin and phenobarbital)
  • Patients must be able to take oral medication without crushing, dissolving or chewing tablets
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

SorafenibIntrons

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-RingDNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenes

Study Officials

  • Christopher Ryan

    SWOG Cancer Research Network

    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

January 7, 2005

First Posted

January 10, 2005

Study Start

September 1, 2004

Primary Completion

May 1, 2006

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

US(1)