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Carcinoma, Renal CellPhase 4NCT00352859

Phase IV Randomization to On-Going Treatment to Evaluate Sustained Sorafenib

A Phase 4 study testing Nexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferon and Gemcitabine or Interferon (only) in people with Carcinoma, Renal Cell, run by Bayer 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

The purpose of this study is to see if taking interferon or gemcitabine along with sorafenib will stop the advanced renal cell cancer from becoming worse in some people. To do this, sorafenib along with gemcitabine or interferon will be compared to treatment with gemcitabine or interferon alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Nexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferon and Gemcitabine or Interferon (only)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Aug 2006to Nov 2006
Phase
Phase 4
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

  • Male or female patients above 18 years of age with advanced RCC who have received sorafenib as their first and only systemic anti-tumor therapy for RCC prior to randomization
  • Patients must have previously tolerated a minimum dose of sorafenib 400 mg daily for at least six weeks prior to study entry and have radiographically documented progressive disease while on sorafenib
  • Patients must have experienced clinical benefit, partial response, complete response or stable disease during their previous course of sorafenib therapy
  • Life expectancy > 12 weeks
  • Patients must meet the Memorial Sloan-Kettering Cancer Center (MSKCC) risk category of low or medium at randomization
  • Patients must give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
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  • Patients must have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • Patients must not have brain metastases
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
  • In addition, the following patients may be included, provided all other inclusion and exclusion criteria are met
  • Patients who have received the vaccines cG250 (monoclonal antibody to carbonic anhydrase IX) or HSPPC-96 (Heat Shock Protein Peptide Complex 96) are eligible provided that they have received no other systemic anti-cancer therapy
  • Patients who were enrolled in the ARCCS treatment protocol

Who cannot join

  • Patients must not have experienced more than three weeks from documented disease progression to randomization
  • Any medical condition requiring the use of systemic corticosteroids during IFN therapy
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1) or any cancer curatively treated within the last three years prior to study entry
  • Severe renal impairment or receiving dialysis
  • More than a two week interruption in sorafenib dosing immediately prior to randomization
  • Patients with a best response of disease progression on their previous course of sorafenib
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  • Patients who meet the MSKCC high risk category at randomization
  • Hemorrhagic episode >= Grade 2 NCI CTC AE v3.0 within last six months
  • History of cardiac disease: congestive heart failure> NYHA class 2; active cardiovascular disease (MI more than six months prior to study entry is allowed); cardiac arrhythmia requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
  • Active clinically serious bacterial or fungal infections (>= Grade 2 NCI CTCAE v3.0)
  • Known history of Human Immunodeficiency Virus (HIV) infection or chronic hepatitis B or C
  • Symptomatic metastatic brain or meningeal tumors unless the patient is > six months from definitive therapy, has a negative CNS imaging study within four weeks of study entry, and is clinically stable off steroids. The patient must not be undergoing acute steroid taper
  • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
  • Ongoing substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial, including history of sensitivity to E. coli-derived products
  • Any condition that is unstable or that could jeopardise the safety of the patient and his/her compliance in the study. Patients with a history of severe depression; patients with clinically significant active autoimmune disorders; history of organ allograft
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days of the start of study treatment. Both men and women enrolled in this trial must use adequate birth control measures during the course of the trial
  • Patients who have had a significant surgical procedure within the past four weeks are excluded
  • Excluded Therapies and Medications, Previous and Concomitant:
  • Any prior or concurrent systemic anti-cancer therapy including chemotherapy, monoclonal antibodies, hormonal therapy or investigational therapy, except for bisphosphonates and sorafenib
  • Biological response modifiers, such as G-CSF or GM-CSF, within three weeks prior to study entry or during study. G-CSF and other hematopoietic growth factors may only be used in the management of acute toxicity such as febrile neutropenia when medically indicated or at the discretion of the Investigator. However, they may not be substituted for a required dose reduction of any study drug
  • Patients taking erythropoietin are permitted provided no dose adjustment is undertaken within two months prior to the study or during the study
  • Concomitant rifampicin or St. John's Wart
  • Palliative therapy will be allowed, patients may receive palliative and supportive care for any underlying illness

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    Kansas City, Missouri

Other trials in United States

About this study

Official title: A Randomized Discontinuation Trial to Determine the Clinical Benefit of Continuation of Sorafenib Following Disease Progression in Patients With Advanced Renal Cell Carcinoma

The purpose of this study is to see if taking interferon or gemcitabine along with sorafenib will stop the advanced renal cell cancer from becoming worse in some people. To do this, sorafenib along with gemcitabine or interferon will be compared to treatment with gemcitabine or interferon alone. More safety information on sorafenib will be also collected. About 260 patients with progressed renal cell cancer will be in this study.

Being tested
Nexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferon, Gemcitabine or Interferon (only)
Keywords
Cancer, Renal Cell Cancer, RCC
Medical subject headings
Carcinoma, Renal Cell, Neoplasms

What participants receive

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

  • Nexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferonDrug

    Continue sorafenib with addition of gemcitabine or interferon

  • Gemcitabine or Interferon (only)Drug

    Discontinue Sorafenib and receive Gemcitabine or Interferon only

Study groups in NCT00352859
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Nexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferon
Arm 2ExperimentalNot described
Receives: Drug: Gemcitabine or Interferon (only)

What is being measured

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

  1. Progression Free Survival (PFS)

    Measured: After 192 progression or death events

Secondary outcomes (6)

  1. Disease Control Rate (DCR)

    Measured: After start of treatment

  2. Overall Best Response

    Measured: Until 30 days after termination of active therapy

  3. Duration of response

    Measured: Time from initial Response to documented Tumor Progression

  4. Time to response

    Measured: Time from the date of randomization to date that an objective tumor response (PR or CR) according to RECIST criteria is first documented

  5. Overall Survival (OS)

    Measured: Time from the date of randomization to date of death

  6. Adverse Event Collection and Tolerability

    Measured: Throughout the whole study

Timeline

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

  1. First posted17 Jul 2006 (estimated)
  2. Study startAug 2006
  3. Study completionNov 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00352859
Sponsor's protocol ID
12178
Status last verified
Dec 2014
First submitted
14 Jul 2006
Last updated
30 Dec 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nexavar (Sorafenib, BAY43-9006) with addition of gemcitabine or interferon and Gemcitabine or Interferon (only) in people with Carcinoma, Renal Cell, run by Bayer 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 12 inclusion and 24 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 30 Dec 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Progression Free Survival (PFS) (time frame: After 192 progression or death events). 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 NCT00352859.

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 30 Dec 2014.

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Clinical Trial NCT00352859 | AzTrials