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
Summary
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 TherapyProgression Free Survival for Re-challenge With Sunitinib Progression Free Survival: Second Line of Treatment Progression Free Survival: Third Line Treatment
Secondary outcome: Overall SurvivalPercentage 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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 .
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
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