Sutent Rechallenge In mRCC Patients
- Conditions
- Metastatic Renal Cell Carcinoma
- Registration Number
- NCT01827254
- Lead Sponsor
- Pfizer
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- 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.
- Patient who didn't receive Sunitinib in first line.
- Patient who received less than one line of treatment .
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival: Second Line of Treatment From start of treatment up to 22.9 months 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).
Progression Free Survival With Sunitinib as First Line of Therapy From start of treatment up to 66.6 months 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.
Progression Free Survival for Re-challenge With Sunitinib From start of treatment up to 52.2 months 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.
Progression Free Survival: Third Line Treatment From start of treatment up to 23.7 months 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).
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Objective Response Baseline up to 98.0 months 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.
Overall Survival Baseline up to death or end of study (up to 98.0 months) 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.
Trial Locations
- Locations (18)
Hopital albert Michalon
🇫🇷Grenoble, Cedex 9, France
Centre Catalan Urologie Andrologie
🇫🇷Cabestany, France
clinique de la Louvière
🇫🇷Lille Cedex, France
Hopital Dupuytren - Oncologie Medicale
🇫🇷Limoges Cedex, France
Hôpital Saint-André
🇫🇷Bordeaux Cedex, France
Hopital Timone Adultes
🇫🇷Marseille Cedex, France
CHU Charles Nicolle
🇫🇷ROUEN Cedex, France
Departement d'Oncologie Medicale-Institut de Cancerologie de la Loire
🇫🇷Saint Priest en Jarez Cedex, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Rene Gauducheau - Service Oncologie Medicale
🇫🇷St Herblain Cedex, France
Centre Leon Berard, Service d'Oncologie Medicale
🇫🇷Lyon Cedex 08, France
CHU de la Timone
🇫🇷Marseille, Cedex 5, France
Centre Paul Papin
🇫🇷Angers, France
Centre Oscar Lambret - Cancérologie Urologie Digestive
🇫🇷Lille Cedex, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre les Nancy, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Institut Paoli-Calmettes / Hôpital de jour
🇫🇷Marseille Cedex 9, France
Hopital Europeen Georges Pompidou
🇫🇷Paris Cedex 15, France