Biological, Pathological and Imagery Markers in the First-line Treatment of Metastatic Clear-cell Renal Cell Carcinoma

• Status: Terminated
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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 metastatic renal cell carcinoma (mRCC). Suntinib, approved for this indication, will be administred before and after nephrectomy and biomarkers sampling and imaging will be operated to monitor the activity and identify prognostic factors in mRCC.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: National Cancer Institute, France; Pfizer
• Treatments: Sunitinib

Criteria

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