Metastatic Renal Cell Carcinoma Clinical Trial
— RESUMEOfficial title:
Etude Resume (Retraitement Sunitinib Rein Metastatique)
Verified date | April 2015 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: French Data Protection Authority |
Study type | Observational |
Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.
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 . |
Observational Model: Cohort, Time Perspective: Retrospective
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00930033 -
Clinical Trial to Assess the Importance of Nephrectomy
|
Phase 3 | |
Recruiting |
NCT05863351 -
Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study
|
Phase 3 | |
Not yet recruiting |
NCT06284564 -
A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)
|
Phase 2 | |
Completed |
NCT00414765 -
Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma
|
Phase 4 | |
Active, not recruiting |
NCT03149822 -
Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT03647878 -
Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.
|
||
Completed |
NCT01517243 -
Phase II Study of Alternating Sunitinib and Temsirolimus
|
Phase 2 | |
Withdrawn |
NCT03927248 -
PAC-1 for Treatment of Refractory, Metastatic Kidney Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT02122003 -
Second Line Sorafenib After Pazopanib in Patients With RCC
|
Phase 2 | |
Completed |
NCT01182142 -
Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients
|
Phase 2 | |
Completed |
NCT00630409 -
Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma
|
Phase 2 | |
Recruiting |
NCT04140526 -
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
|
Phase 1/Phase 2 | |
Completed |
NCT04076787 -
Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
|
||
Active, not recruiting |
NCT04467021 -
Cancer and Blood Pressure Management, CARISMA Study
|
N/A | |
Recruiting |
NCT05119335 -
A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma
|
Phase 1/Phase 2 | |
Completed |
NCT02282579 -
Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy
|
||
Completed |
NCT01731158 -
Sequential Therapy in Metastatic Renal Cell Carinoma
|
Phase 2 | |
Terminated |
NCT02071641 -
Phase II Study of Sunitinib Rechallenge in Patients With Metastatic Renal Cell Carcinoma
|
Phase 2 | |
Terminated |
NCT01342627 -
Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT01274273 -
Study of Interleukin-2, Interferon-alpha and Bevacizumab in Metastatic Kidney Cancer
|
Phase 2 |