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Trial record 1 of 1 for:    NCT00930345
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Biological, Pathological and Imagery Markers in the First-line Treatment of Metastatic Clear-cell Renal Cell Carcinoma (PREINSUT)

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ClinicalTrials.gov Identifier: NCT00930345
Recruitment Status : Terminated
First Posted : June 30, 2009
Last Update Posted : April 1, 2015
National Cancer Institute, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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 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.

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Drug: Sunitinib (SUTENT) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Biological, Pathological and Imagery Markers in the First-line Treatment of Metastatic Clear-cell Renal Cell Carcinoma With Sunitinib BEFORE and AFTER Nephrectomy
Study Start Date : December 2008
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
SUTENT before nephrectomy Drug: Sunitinib (SUTENT)

Sunitinib, SUTENT, 50 mg daily p.o., on schedule 4/2, for 2 cycles. Two weeks of rest prior to surgery (week 11 and 12).

Radical nephrectomy at the end of week 12. Sunitinib 50 mg/d, schedule 4/2, reintroduced 2 weeks after surgery (week 14, may be postponed by one or two weeks if wound healing delay or surgical complications). Treatment until disease progression, unacceptable toxicity or consent withdrawal. Dose reduction depending on the type and severity of toxicity.

At the end of the treatment period patients will be treated at the discretion of the Investigator.

Primary Outcome Measures :
  1. To evaluate the prognostic value of several factors (biomarkers and imaging) to identify responders [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. To determine the objective response rate after initiation of treatment in the primitive tumour, according to the RECIST criteria. [ Time Frame: 12 weeks ]
  2. To assess the pathological response (tumoral extension), Progression Free Survival (PFS) as defined by pProgression Free Survival (PFS) as defined by progression of metastasis, overall survival (OS). [ Time Frame: 24 months ]
  3. To evaluate the correlation between tumor extension as defined by the pathologist and the tumor reduction between initiation of treatment and nephrectomy as measured by CT scan [ Time Frame: 12 weeks ]
  4. To compare marker expression in the biopsy (before treatment) and in the primitive tumor. [ Time Frame: 12 weeks ]
  5. To evaluate the ability of investigated biomarkers and VEGF-A gene polymorphisms to be prognostic of the pathological response and of the Progression Free Survival. [ Time Frame: 24 months ]
  6. To evaluate the correlation between the imaging obtained with Dynamic Contrast-enhanced CT scan, with contrast-enhanced US and VEGF expression [ Time Frame: 6 weeks ]
  7. To explore the pharmacokinetic of Sunitinib at study state [ Time Frame: 4 weeks ]
  8. To monitor the potential renal toxicity of Sunitinib [ Time Frame: 24 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930345

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Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Cancer Institute, France
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Principal Investigator: Stephane OUDARD, MD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00930345    
Other Study ID Numbers: P070104
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: May 2009
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Renal cell carcinoma
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action