Study in Non-Clear Cell Renal Carcinoma (Ncc-RCC) Temsirolimus Versus Sunitinib
NCT ID: NCT00979966
Last Updated: 2012-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2009-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Temsirolimus
Temsirolimus
25 mg intravenously, once weekly infusion
B
Sunitinib
Sunitinib
50 mg oral once daily for 4 weeks, followed by 2 weeks rest.
Interventions
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Temsirolimus
25 mg intravenously, once weekly infusion
Sunitinib
50 mg oral once daily for 4 weeks, followed by 2 weeks rest.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Central European Society for Anticancer Drug Research
OTHER
Responsible Party
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Locations
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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
Countries
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References
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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.
Related Links
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German description on the CESAR homepage
Other Identifiers
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C-II-006 / 2009-010143-13
Identifier Type: -
Identifier Source: org_study_id