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Non-clear Cell Renal Cell CancerPhase 2NCT00979966

Study in Non-Clear Cell Renal Carcinoma (Ncc-RCC) Temsirolimus Versus Sunitinib

A Phase 2 study testing Temsirolimus and Sunitinib in people with Non-clear Cell Renal Cell Cancer, run by Central European Society for Anticancer Drug Research at 14 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be a prospective, open-label, randomized multicenter phase-II study to evaluate progression free survival (PFS) in patients with locally advanced or metastatic non-clear cell renal cell cancer (ncc-RCC) receiving Temsirolimus in comparison to Sunitinib. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-clear Cell Renal Cell Cancer
What is being tested?
Temsirolimus and Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
14 sitesGermany
Study dates
Jul 2009to Jul 2012
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

  • Adult males and females: ≥18 years of age.
  • Locally advanced or metastatic, histological confirmed, non-clear cell RCC of all subtypes. Patients must have advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified.
  • Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) If prior palliative radiotherapy to metastatic lesions: ≥ 1 measurable lesion that has not been irradiated.
  • PS 0-2 ECOG
  • Signed written informed consent.
  • White blood cell count (WBC) ≥4x10*9/L with neutrophils ≥1.5 x 10*9/L, platelet count ≥100x10*9/L, hemoglobin ≥9 g/dL.]
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  • Total bilirubin <2 x upper limit of normal.
  • AST and ALT <2.5 x upper limit of normal, or <5 x upper limit of normal in case of liver metastases.
  • Serum creatinine <2.0 x upper limit of normal.
  • Normal ECG without QT prolongation (QTc < 450msec).
  • Adequate cardiac function (left ventricular ejection fraction > 40% as assessed by ECHO.

Who cannot join

  • Predominant clear-cell RCC
  • Resectability or other curative options
  • Any investigational drug within the 30 days before inclusion.
  • Prior systemic treatment for their RCC.
  • Known or suspected allergy or hypersensitivity reaction to any of the components of study treatments.
  • Radiotherapy within the last 4 weeks.
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  • Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
  • Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial.
  • Clinically symptomatic brain or meningeal metastasis. (known or suspected)
  • Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin).
  • History of any of the following cardiac events within the past 6 months:
  • myocardial infarction (including severe/unstable angina),
  • coronary/peripheral artery bypass graft,
  • congestive heart failure (CHF),
  • cerebrovascular accident,
  • transient ischemic attack,
  • pulmonary embolism.
  • No hemorrhage ≥ grade 3 within the past 4 weeks
  • Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of ≥3 anti-hypertensive drugs
  • History of relevant pulmonary hypertension or interstitial lung disease.
  • Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea
  • Previous malignancy (other than renal cancer cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor [Ta, Tis and T1].
  • History of organ allograft
  • Significant disease which, in the investigator's opinion would exclude the patient from the study
  • Patients with seizure and epileptic disorder or other conditions requiring medication (such as phenytoin, carbamazepin, phenobarbital)
  • Patients under strong inducers or inhibitors to CYP Isoenzymes
  • Patients with hypersensitivity to the antihistamine or patients who cannot receive the antihistamine for other medical reasons
  • Patients requiring long-term cortisone therapy
  • Patients requiring oral anticoagulation treatment, such as marcoumar. (Anticoagulation treatment with heparin or low molecular weight heparin [LMWH] is allowed provided that close monitoring is performed).
  • Surgery within at least 2 weeks prior to randomization
  • HIV seropositivity.
  • Abnormal pulmonary function (DLCO < 50%). [Pulmonary function tests need only to be performed if abnormal pulmonary function present in medical history].
  • Poorly controlled diabetes mellitus.
  • Liver cirrhosis, chronic hepatitis
  • Legal incapacity or limited legal capacity
  • Known alcohol or drug abuse.
  • Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Germany14 sites

  • Charité - Campus Virchow Klinikum

    Berlin

  • Charité - Mitte

    Berlin

  • Vivantes Klinikum am Urban

    Berlin

  • Evangelische Kliniken Bonn gGmbH - Johanniter-Krankenhaus

    Bonn

  • Universitätsklinikum Düsseldorf

    Düsseldorf

  • Universitätsklinikum Essen

    Essen

  • Klinikum der J.W. Goethe Universität

    Frankfurt

  • Martin-Luther-Universität Halle-Wittenberg

    Halle

  • Universitätskrankenhaus Jena

    Jena

  • UK-SH Campus Lübeck

    Lübeck

  • Klinikum Oldenburg gGmbH

    Oldenburg

  • Klinikum Stuttgart, Katharinenhospital

    Stuttgart

  • Facharzt für Innere Medizin,

    Viersen

  • Kliniken Nordoberpfalz AG - Klinikum Weiden

    Weiden

Other trials in Germany

About this study

Official title: Prospective Randomized Phase-II Trial With Temsirolimus Versus Sunitinib in Previously Untreated Patients With Advanced or Metastatic Non-Clear Cell Renal Carcinoma

This will be a prospective, open-label, randomized multicenter phase-II study to evaluate progression free survival (PFS) in patients with locally advanced or metastatic non-clear cell renal cell cancer (ncc-RCC) receiving Temsirolimus in comparison to Sunitinib.

In most clinical trials in renal cell carcinoma (RCC), clear cell RCC have been included exclusively. There are only some limited data on the efficacy of Temsirolimus or Sunitinib in ncc-RCC showing interesting response rates for both agents. However, randomized clinical trials in this specific patient population have not yet been performed.

In the proposed study a comparison Temsirolimus and Sunitinib is scheduled in first line therapy of ncc-RCC.

Being tested
Temsirolimus, Sunitinib
Keywords
Locally advanced or metastatic non-clear cell renal cell cancer (ncc-RCC)

What participants receive

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

  • TemsirolimusDrug

    25 mg intravenously, once weekly infusion

  • SunitinibDrug

    50 mg oral once daily for 4 weeks, followed by 2 weeks rest.

Study groups in NCT00979966
Study groupRoleWhat they receive
AExperimentalTemsirolimus
Receives: Drug: Temsirolimus
BExperimentalSunitinib
Receives: Drug: Sunitinib

What is being measured

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

  1. Time to progression

    Measured: 7-11 months expected

Secondary outcomes (4)

  1. Objective response

    Measured: 7-11 months expected

  2. safety assessed using CTCAE v3.0 and safety assessed according to reported SAEs

    Measured: 8-12 months (treatment duration + 1 months)

  3. one year progression free survival rate (1YPFSR)

    Measured: 1 year

  4. overall survival (OS)

    Measured: will be evaluated in 2013

Timeline

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

  1. First posted18 Sep 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJul 2012

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00979966
Sponsor's protocol ID
C-II-006 / 2009-010143-13
Status last verified
Jul 2012
First submitted
9 Sep 2009
Last updated
10 Jul 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

    PubMed 37146227

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Temsirolimus and Sunitinib in people with Non-clear Cell Renal Cell Cancer, run by Central European Society for Anticancer Drug Research at 14 sites in Germany.

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 11 inclusion and 37 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: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time to progression (time frame: 7-11 months expected). 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 NCT00979966, which also lists 1 linked publication.

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 10 Jul 2012.

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