Clinical trial NCT01827254: Sutent Rechallenge In mRCC Patients
Official title: Etude Resume (Retraitement Sunitinib Rein Metastatique)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma
Keywords: sutent rechallenge
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-04-09
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: mRCC patients treated with sunitinib in first line and rechallenged with sunitinib in 3rd and 4th line

Brief summary: Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.

Detailed description: A sample size of n = 40 patients will allow to estimate of the median PFS with a precision around 1.8 months (based on data from Rini et al.) This retrospective and prospective study is designed to estimate the effect of Sutent rechallenge.

The PFS (estimated from Kaplan-Meier estimate) will be the primary endpoints. In addition, the effects of sunitinib at the 2 periods of treatment (i.e. first line sunitinib vs. rechallenge) will be compared by Wilcoxon signed-rank test for PFS values and by McNemar test for overall response rate (ORR).

Eligibility criteria: Inclusion Criteria:

* Histologically documented metastatic RCC containing predominantly clear cell component.
* Previously received sunitinib in first line, 2 or more antitumor therapies subsequently and then received sunitinib for a second time.
* At least 1 cycle of sunitinib rechallenge (1 cycle= 4 weeks on/2 weeks off).
* At least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter (LD) ³ 10 mm when measured by spiral computerized tomography (CT) (5-mm slice thickness contiguous) or ³ 20 mm when measured by conventional CT (10-mm slice thickness contiguous). The lesion must be ³ 2 times the size of the slice thickness per RECIST criteria.
* Life expectancy of at least 3 months.

Exclusion Criteria:

* Patient who didn't receive Sunitinib in first line.
* Patient who received less than one line of treatment .

Primary outcomes:
measure: Progression Free Survival With Sunitinib as First Line of Therapy
timeFrame: From start of treatment up to 66.6 months
measure: Progression Free Survival for Re-challenge With Sunitinib
timeFrame: From start of treatment up to 52.2 months
measure: Progression Free Survival: Second Line of Treatment
timeFrame: From start of treatment up to 22.9 months
measure: Progression Free Survival: Third Line Treatment
timeFrame: From start of treatment up to 23.7 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Baseline up to death or end of study (up to 98.0 months)
measure: Percentage of Participants With Objective Response
timeFrame: Baseline up to 98.0 months
Other outcomes:
measure: Number of Participant With Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 24 months
Locations:
city: Marseille
country: France
facility: CHU de la Timone
state: Cedex 5
city: Grenoble
country: France
facility: Hopital albert Michalon
state: Cedex 9
city: Angers
country: France
facility: Centre Paul Papin
city: Bordeaux Cedex
country: France
facility: Hôpital Saint-André
city: Cabestany
country: France
facility: Centre Catalan Urologie Andrologie
city: Lille Cedex
country: France
facility: Centre Oscar Lambret - Cancérologie Urologie Digestive
city: Lille Cedex
country: France
facility: clinique de la Louvière
city: Limoges Cedex
country: France
facility: Hopital Dupuytren - Oncologie Medicale
city: Lyon Cedex 08
country: France
facility: Centre Leon Berard, Service d'Oncologie Medicale
city: Marseille Cedex 9
country: France
facility: Institut Paoli-Calmettes / Hôpital de jour
city: Marseille Cedex
country: France
facility: Hopital Timone Adultes
city: Paris Cedex 15
country: France
facility: Hopital Europeen Georges Pompidou
city: Rennes
country: France
facility: Centre Eugene Marquis
city: ROUEN Cedex
country: France
facility: CHU Charles Nicolle
city: Saint Priest en Jarez Cedex
country: France
facility: Departement d'Oncologie Medicale-Institut de Cancerologie de la Loire
city: St Herblain Cedex
country: France
facility: Centre Rene Gauducheau - Service Oncologie Medicale
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Vandoeuvre les Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: