NCT00930345

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

April 1, 2015

Status Verified

May 1, 2009

Enrollment Period

4.8 years

First QC Date

June 29, 2009

Last Update Submit

March 31, 2015

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Renal cell carcinomaAntiangiogenicsBiomarkersImagery

Outcome Measures

Primary Outcomes (1)

  • To evaluate the prognostic value of several factors (biomarkers and imaging) to identify responders

    36 weeks

Secondary Outcomes (8)

  • To determine the objective response rate after initiation of treatment in the primitive tumour, according to the RECIST criteria.

    12 weeks

  • 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).

    24 months

  • 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

    12 weeks

  • To compare marker expression in the biopsy (before treatment) and in the primitive tumor.

    12 weeks

  • 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.

    24 months

  • +3 more secondary outcomes

Study Arms (1)

SUTENT before nephrectomy

OTHER
Drug: Sunitinib (SUTENT)

Interventions

Sunitinib (SUTENT)DRUG

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.

SUTENT before nephrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HEGP

Paris, 75015, France

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Stephane OUDARD, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2009

First Posted

June 30, 2009

Study Start

December 1, 2008

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

April 1, 2015

Record last verified: 2009-05

Locations

FR(1)