Status:
TERMINATED
Biological, Pathological and Imagery Markers in the First-line Treatment of Metastatic Clear-cell Renal Cell Carcinoma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Pfizer
National Cancer Institute, France
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to identify and/or validate biomarkers and imaging markers to predict and monitor the activity of a new class of therapeutic agents called antiangiogenics for the treatment of...
Detailed Description
BACKGROUND Sunitinib, SUTENT, is a promising multi-target TKI in the treatment of metastatic renal cell carcinoma after cytokine failure. In previous phase II studies, ORR is 40% and TTP = 8,7 months....
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Patients with renal tumor in place, resectable, with at least one measurable metastasis 1.5 cm and indication of antiangiogenic therapy
- Histopathologically confirmed clear cell renal cell carcinoma (biopsy) and possibility of adequate tumor sampling prior to treatment
- No prior systemic treatment for RCC
- Male or female, 18 years
- Performance status ECOG 0-1
- Life expectancy 3 months
- Adequate organ function as defined by the following criteria:
- Total serum bilirubin 2 x ULN (Gilbert's disease exempt)
- Serum transaminases and alcalines phosphatases 2.5 x ULN, or in case of liver or bone metastasis 5x ULN
- Serum creatinine 2 x ULN, creatinine clearance 80 ml/mn
- Absolute neutrophil count (ANC) 1500/mm3
- Platelets 100,000/mm3
- Hemoglobin 10.0 g/dL
- INR 1.7 or prothrobin time (PT) 6sec over
- Negative pregnancy test within 7 days prior to registration
- Signed and dated IRB/ICE-approved informed consent.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- Patient covered by the national health system
- Exclusion criteria :
- Previous nephrectomy
- Renal sarcoma, papillary tumors or collecting duct carcinoma
- Treatment in a clinical trial in the last 30 days
- Previous treatment with Sunitinib or other antiangiogenics
- Any of the following within 12 months prior to treatment initiation: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, thrombo-embolic accident or cerebrovascular accident including transient ischemic attack.
- Uncontrolled hypertension defined as systolic blood pressure \>150mmHg or diastolic pressure \>90mmHg, despite optimal medical treatment
- Ongoing cardiac dysrhythmia of grade 2, atrial fibrillation of any grade, QTc interval \>0.50
- Treatment with anticoagulant agents and treatment with therapeutic doses of warfarin within 2 weeks prior to first day of Sunitinib. Low dose warfarin for deep vein thrombosis prophylaxis is permitted up to 2mg/day. Low molecular weight heparin or aspirin are allowed
- Any medical condition that might interfere with oral medication absorption
- Brain metastasis. Note: Brain scan or MRI is mandatory
- LVEF value \< 50%
- Prior radiation therapy.
- Pregnancy or breastfeeding. Women and men must agree to use effective contraception during the study period. Acceptable contraception includes implants, oral contraceptives, intrauterine devices, surgical sterilization.
- Any acute or chronic medical or psychiatric condition or laboratory abnormality that would make the patient inappropriate with this study.
- Any second malignancy within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ and pT1/a bladder cancer with no evidence of recurrent disease for 12 months.
- Hypersensitivity to the Sunitinib malate or any excipient of Sutent
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00930345
Start Date
December 1 2008
End Date
October 1 2013
Last Update
April 1 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
HEGP
Paris, France, 75015