Sutent Rechallenge In mRCC Patients (RESUME)

Etude Resume (Retraitement Sunitinib Rein Metastatique)

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

Study Overview

• Status: Completed
• Conditions: Metastatic Renal Cell Carcinoma
• Intervention / Treatment: Other: sunitinib: observational study

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).

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • Centre Paul Papin
  • Bordeaux Cedex, France, 33075
    • Hôpital Saint-André
  • Cabestany, France, 66330
    • Centre Catalan Urologie Andrologie
  • Lille Cedex, France, 59020
    • Centre Oscar Lambret - Cancérologie Urologie Digestive
  • Lille Cedex, France, 59042
    • Clinique de la Louvière
  • Limoges Cedex, France, 87042
    • Hopital Dupuytren - Oncologie Medicale
  • Lyon Cedex 08, France, 69373
    • Centre Léon Bérard, Service d'Oncologie Médicale
  • Marseille Cedex, France, 13385
    • Hopital Timone Adultes
  • Marseille Cedex 9, France, 13273 Cedex 9
    • Institut Paoli-Calmettes / Hôpital de jour
  • Paris Cedex 15, France, 75908
    • Hôpital Européen Georges Pompidou
  • ROUEN Cedex, France, 76031
    • CHU Charles Nicolle
  • Rennes, France, 35042
    • Centre Eugene Marquis
  • Saint Priest en Jarez Cedex, France, 42271
    • Departement d'Oncologie Medicale-Institut de Cancerologie de la Loire
  • St Herblain Cedex, France, 44805
    • Centre Rene Gauducheau - Service Oncologie Medicale
  • Toulouse, France, 31000
    • Institut Claudius Regaud
  • Vandoeuvre les Nancy, France, 54511
    • Centre Alexis Vautrin
  • Cedex 5
    • Marseille, Cedex 5, France, 13335
      • CHU de la Timone
  • Cedex 9
    • Grenoble, Cedex 9, France, 38043
      • Hopital albert Michalon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

mRCC patients treated with sunitinib in first line and rechallenged with sunitinib in 3rd and 4th line

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-Interventional Study	Other: sunitinib: observational study; Observational study evaluating patients who were treated with sunitinib in 1st line and in 3rd line; Other Names: sunitinib 50 mg 4/2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: March 25, 2013
• First Submitted That Met QC Criteria: April 4, 2013
• First Posted (Estimate): April 9, 2013

Study Record Updates

• Last Update Posted (Estimate): April 30, 2015
• Last Update Submitted That Met QC Criteria: April 28, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: sutent rechallenge
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: A6181211; ETUDE RESUME (Other Identifier: Alias Study Number)