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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00979966
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):
Central European Society for Anticancer Drug Research

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Non-clear Cell Renal Cell Cancer Drug: Temsirolimus Drug: Sunitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Phase-II Trial With Temsirolimus Versus Sunitinib in Previously Untreated Patients With Advanced or Metastatic Non-Clear Cell Renal Carcinoma
Study Start Date : July 2009
Actual Primary Completion Date : July 2012

Arm Intervention/treatment
Experimental: A
Drug: Temsirolimus
25 mg intravenously, once weekly infusion

Experimental: B
Drug: Sunitinib
50 mg oral once daily for 4 weeks, followed by 2 weeks rest.

Primary Outcome Measures :
  1. Time to progression [ Time Frame: 7-11 months expected ]

Secondary Outcome Measures :
  1. Objective response [ Time Frame: 7-11 months expected ]
  2. safety assessed using CTCAE v3.0 and safety assessed according to reported SAEs [ Time Frame: 8-12 months (treatment duration + 1 months) ]
  3. one year progression free survival rate (1YPFSR) [ Time Frame: 1 year ]
  4. overall survival (OS) [ Time Frame: will be evaluated in 2013 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adult males and females: ≥18 years of age.
  2. 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.
  3. 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.
  4. PS 0-2 ECOG
  5. Signed written informed consent.
  6. 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.]
  7. Total bilirubin <2 x upper limit of normal.
  8. AST and ALT <2.5 x upper limit of normal, or <5 x upper limit of normal in case of liver metastases.
  9. Serum creatinine <2.0 x upper limit of normal.
  10. Normal ECG without QT prolongation (QTc < 450msec).
  11. Adequate cardiac function (left ventricular ejection fraction > 40% as assessed by ECHO.

Exclusion Criteria:

  1. Predominant clear-cell RCC
  2. Resectability or other curative options
  3. Any investigational drug within the 30 days before inclusion.
  4. Prior systemic treatment for their RCC.
  5. Known or suspected allergy or hypersensitivity reaction to any of the components of study treatments.
  6. Radiotherapy within the last 4 weeks.
  7. Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
  8. Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial.
  9. Clinically symptomatic brain or meningeal metastasis. (known or suspected)
  10. Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin).
  11. 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.
  12. No hemorrhage ≥ grade 3 within the past 4 weeks
  13. Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of ≥3 anti-hypertensive drugs
  14. History of relevant pulmonary hypertension or interstitial lung disease.
  15. Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea
  16. 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].
  17. History of organ allograft
  18. Significant disease which, in the investigator`s opinion would exclude the patient from the study
  19. Patients with seizure and epileptic disorder or other conditions requiring medication (such as phenytoin, carbamazepin, phenobarbital)
  20. Patients under strong inducers or inhibitors to CYP Isoenzymes
  21. Patients with hypersensitivity to the antihistamine or patients who cannot receive the antihistamine for other medical reasons
  22. Patients requiring long-term cortisone therapy
  23. 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).
  24. Surgery within at least 2 weeks prior to randomization
  25. HIV seropositivity.
  26. Abnormal pulmonary function (DLCO < 50%). [Pulmonary function tests need only to be performed if abnormal pulmonary function present in medical history].
  27. Poorly controlled diabetes mellitus.
  28. Liver cirrhosis, chronic hepatitis
  29. Legal incapacity or limited legal capacity
  30. Known alcohol or drug abuse.
  31. Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00979966

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Charité - Campus Virchow Klinikum
Berlin, Germany
Charité - Mitte
Berlin, Germany
Vivantes Klinikum am Urban
Berlin, Germany
Evangelische Kliniken Bonn gGmbH - Johanniter-Krankenhaus
Bonn, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Essen
Essen, Germany
Klinikum der J.W. Goethe Universität
Frankfurt, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, Germany
Universitätskrankenhaus Jena
Jena, Germany
UK-SH Campus Lübeck
Lübeck, Germany
Klinikum Oldenburg gGmbH
Oldenburg, Germany
Klinikum Stuttgart, Katharinenhospital
Stuttgart, Germany
Facharzt für Innere Medizin,
Viersen, Germany
Kliniken Nordoberpfalz AG - Klinikum Weiden
Weiden, Germany
Sponsors and Collaborators
Central European Society for Anticancer Drug Research
Additional Information:
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Responsible Party: Central European Society for Anticancer Drug Research Identifier: NCT00979966    
Other Study ID Numbers: C-II-006 / 2009-010143-13
First Posted: September 18, 2009    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012
Keywords provided by Central European Society for Anticancer Drug Research:
Locally advanced or metastatic non-clear cell renal cell cancer (ncc-RCC)
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors