Status:
COMPLETED
Study in Non-Clear Cell Renal Carcinoma (Ncc-RCC) Temsirolimus Versus Sunitinib
Lead Sponsor:
Central European Society for Anticancer Drug Research
Conditions:
Non-clear Cell Renal Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 canc...
Eligibility Criteria
Inclusion
- 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.\]
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00979966
Start Date
July 1 2009
Last Update
July 10 2012
Active Locations (14)
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1
Charité - Campus Virchow Klinikum
Berlin, Germany
2
Charité - Mitte
Berlin, Germany
3
Vivantes Klinikum am Urban
Berlin, Germany
4
Evangelische Kliniken Bonn gGmbH - Johanniter-Krankenhaus
Bonn, Germany