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Sutent Rechallenge In mRCC Patients

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Renal Cell Carcinoma

Intervention: sunitinib: observational study (Other)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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

Clinical Details

Official title: Etude Resume (Retraitement Sunitinib Rein Metastatique)

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome:

Progression Free Survival With Sunitinib as First Line of Therapy

Progression Free Survival for Re-challenge With Sunitinib

Progression Free Survival: Second Line of Treatment

Progression Free Survival: Third Line Treatment

Secondary outcome:

Overall Survival

Percentage of Participants With Objective Response

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).


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Histologically documented metastatic RCC containing predominantly clear cell


- 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 .

Locations and Contacts

Centre Paul Papin, Angers 49100, France

Hôpital Saint-André, Bordeaux Cedex 33075, France

Centre Catalan Urologie Andrologie, Cabestany 66330, France

Centre Oscar Lambret - Cancérologie Urologie Digestive, Lille Cedex 59020, France

clinique de la Louvière, Lille Cedex 59042, France

Hopital Dupuytren - Oncologie Medicale, Limoges Cedex 87042, France

Centre Leon Berard, Service d'Oncologie Medicale, Lyon Cedex 08 69373, France

Institut Paoli-Calmettes / Hôpital de jour, Marseille Cedex 9 13273 Cedex 9, France

Hopital Timone Adultes, Marseille Cedex 13385, France

Hopital Europeen Georges Pompidou, Paris Cedex 15 75908, France

Centre Eugene Marquis, Rennes 35042, France

CHU Charles Nicolle, ROUEN Cedex 76031, France

Departement d'Oncologie Medicale-Institut de Cancerologie de la Loire, Saint Priest en Jarez Cedex 42271, France

Centre Rene Gauducheau - Service Oncologie Medicale, St Herblain Cedex 44805, France

Institut Claudius Regaud, Toulouse 31000, France

Centre Alexis Vautrin, Vandoeuvre les Nancy 54511, France

CHU de la Timone, Marseille, Cedex 5 13335, France

Hopital albert Michalon, Grenoble, Cedex 9 38043, France

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2013
Last updated: April 28, 2015

Page last updated: August 23, 2015

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