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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Central European Society for Anticancer Drug Research
ClinicalTrials.gov Identifier:
NCT00979966
First received: September 9, 2009
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Non-clear Cell Renal Cell Cancer
Drug: Temsirolimus
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Central European Society for Anticancer Drug Research:

Primary Outcome Measures:
  • Time to progression [ Time Frame: 7-11 months expected ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response [ Time Frame: 7-11 months expected ] [ Designated as safety issue: No ]
  • safety assessed using CTCAE v3.0 and safety assessed according to reported SAEs [ Time Frame: 8-12 months (treatment duration + 1 months) ] [ Designated as safety issue: Yes ]
  • one year progression free survival rate (1YPFSR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • overall survival (OS) [ Time Frame: will be evaluated in 2013 ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: July 2009
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Temsirolimus
Drug: Temsirolimus
25 mg intravenously, once weekly infusion
Experimental: B
Sunitinib
Drug: Sunitinib
50 mg oral once daily for 4 weeks, followed by 2 weeks rest.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979966

Locations
Germany
Vivantes Klinikum am Urban
Berlin, Germany
Charité - Campus Virchow Klinikum
Berlin, Germany
Charité - Mitte
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
  More Information

Additional Information:
No publications provided

Responsible Party: Central European Society for Anticancer Drug Research
ClinicalTrials.gov Identifier: NCT00979966     History of Changes
Other Study ID Numbers: C-II-006 / 2009-010143-13
Study First Received: September 9, 2009
Last Updated: July 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sirolimus
Everolimus
Sunitinib
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014