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Clear Cell Renal Cell CarcinomaPhase 2NCT00098618

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

A Phase 2 study testing sorafenib tosylate, recombinant interferon alfa and laboratory biomarker analysis in people with Clear Cell Renal Cell Carcinoma and Papillary Renal Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sorafenib tosylate, recombinant interferon alfa and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Oct 2004to Jan 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 42Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: A Phase 2 Study Of BAY 43-9006 In Combination With Interferon Alfa-2b In Metastatic Renal Cell Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
sorafenib tosylate, recombinant interferon alfa, laboratory biomarker analysis
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sorafenib tosylateDrug

    Also called BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar

    Given orally

  • recombinant interferon alfaBiological

    Also called Alferon N, alpha interferon, IFN-A, Intron A

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00098618
Study groupRoleWhat they receive
Treatment (sorafenib tosylate and recombinant interferon alfa)ExperimentalPatients 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
Receives: Drug: sorafenib tosylate; Biological: recombinant interferon alfa; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (CR+PR) using RECIST criteria

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

    Measured: Up to 5 years

  2. 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.

    Measured: Up to 5 years

  3. Progression-free survival

    Kaplan-Meier curves will be used.

    Measured: Up to 5 years

  4. Overall survival

    Kaplan-Meier curves will be used.

    Measured: Up to 5 years

  5. Duration of response

    Kaplan-Meier curves will be used.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2004 (estimated)
  2. Study startOct 2004
  3. Primary completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00098618
Sponsor's protocol ID
NCI-2012-02638
Other IDs
6258-04-9R0, NCI-6553, CDR0000398171, U01CA099118
Status last verified
Jul 2013
First submitted
7 Dec 2004
Last updated
2 Jul 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib tosylate, recombinant interferon alfa and laboratory biomarker analysis in people with Clear Cell Renal Cell Carcinoma and Papillary Renal Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 42 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (CR+PR) using RECIST criteria (time frame: Up to 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00098618.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013.

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