Sutent Rechallenge In mRCC Patients

Metastatic Renal Cell Carcinoma Clinical Trial

— RESUME  

Official title:

Etude Resume (Retraitement Sunitinib Rein Metastatique)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827254
• Other study ID #: A6181211
• Secondary ID: ETUDE RESUME
• Status: Completed
• Phase: N/A
• First received: March 25, 2013
• Last updated: April 28, 2015
• Start date: July 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 .

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Other:
• sunitinib: observational study
Observational study evaluating patients who were treated with sunitinib in 1st line and in 3rd line

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Hôpital Saint-André	Bordeaux Cedex
France	Centre Catalan Urologie Andrologie	Cabestany
France	Hopital albert Michalon	Grenoble	Cedex 9
France	Centre Oscar Lambret - Cancérologie Urologie Digestive	Lille Cedex
France	clinique de la Louvière	Lille Cedex
France	Hopital Dupuytren - Oncologie Medicale	Limoges Cedex
France	Centre Leon Berard, Service d'Oncologie Medicale	Lyon Cedex 08
France	CHU de la Timone	Marseille	Cedex 5
France	Hopital Timone Adultes	Marseille Cedex
France	Institut Paoli-Calmettes / Hôpital de jour	Marseille Cedex 9
France	Hopital Europeen Georges Pompidou	Paris Cedex 15
France	Centre Eugene Marquis	Rennes
France	CHU Charles Nicolle	ROUEN Cedex
France	Departement d'Oncologie Medicale-Institut de Cancerologie de la Loire	Saint Priest en Jarez Cedex
France	Centre Rene Gauducheau - Service Oncologie Medicale	St Herblain Cedex
France	Institut Claudius Regaud	Toulouse
France	Centre Alexis Vautrin	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participant With Adverse Events (AEs) or Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs include both serious as well as non-serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Baseline up to 24 months	Yes
Primary	Progression Free Survival With Sunitinib as First Line of Therapy	The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.	From start of treatment up to 66.6 months	No
Primary	Progression Free Survival for Re-challenge With Sunitinib	The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.	From start of treatment up to 52.2 months	No
Primary	Progression Free Survival: Second Line of Treatment	The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Second-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).	From start of treatment up to 22.9 months	No
Primary	Progression Free Survival: Third Line Treatment	The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Third-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).	From start of treatment up to 23.7 months	No
Secondary	Overall Survival	Overall survival of patients under treatment was evaluated by calculating the time between date of initiation of treatment (1st line) and date of death, if the latter occurred before the end of the study. Duration of Overall Survival =(Date of death - Start date of treatment) + 1)/365.25 x 12.	Baseline up to death or end of study (up to 98.0 months)	No
Secondary	Percentage of Participants With Objective Response	Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Percentage of participants with objective response was calculated for the 1st-line of therapy with Sunitinib, Sunitinib re-challenge and for retreatment with Sunitinib as 3rd-line of therapy or more.	Baseline up to 98.0 months	No

External Links

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