Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer
Phase II of Sunitinib (SUTENT®) in First Line for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma - SUPAP
5 other identifiers
interventional
92
1 country
22
Brief Summary
RATIONALE: Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib works as first-line therapy in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2007
Longer than P75 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 5, 2007
CompletedFirst Submitted
Initial submission to the registry
October 5, 2007
CompletedFirst Posted
Study publicly available on registry
October 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFebruary 21, 2021
February 1, 2021
3.4 years
October 5, 2007
February 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective tumor response rate
Secondary Outcomes (5)
Safety
Overall survival
Time to disease progression
Time to response
Duration of response
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of papillary renal cell carcinoma
- Locally advanced or metastatic disease
- Type I or type II disease
- Progressive disease
- Measurable disease defined by RECIST criteria as at least 1 lesion at least 2 cm in length by conventional CT scan techniques or at least 1 cm by spiral CT scan
- No brain metastases including treated and nonprogressive metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8 g/dL
- Total bilirubin ≤ 3 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Serum creatinine \< 1.5 times ULN
- +5 more criteria
You may not qualify if:
- NCI CTC grade 3 hemorrhage within 4 weeks prior to start of study treatment
- Diagnosis of any second malignancy within the past 3 years except for basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix that has been adequately treated with no evidence of recurrent disease within the past 12 months
- Spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
- Any of the following within the past 12 months prior to study drug administration:
- Severe/unstable angina
- Myocardial infarction
- Coronary artery bypass graft
- Symptomatic congestive heart failure
- Cerebrovascular accident including transient ischemic attack
- Pulmonary embolism
- Any of the following conditions:
- Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2
- Atrial fibrillation of any grade
- Prolongation of the QTc interval to \> 450 msec for males or \> 470 msec for females
- Hypertension that cannot be controlled by medications
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (22)
Centre Paul Papin
Angers, 49036, France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, 25030, France
Hopital Saint Andre
Bordeaux, 33075, France
C.H.U. de Brest
Brest, 29609, France
Centre Regional Francois Baclesse
Caen, 14076, France
CHU de Grenoble - Hopital de la Tronche
Grenoble, 38043, France
Centre Hospitalier Departemental
La Roche-sur-Yon, 85025, France
Centre Oscar Lambret
Lille, 59020, France
Centre Leon Berard
Lyon, 69373, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, 13273, France
CHU de la Timone
Marseille, 13385, France
Hopital Notre-Dame de Bon Secours
Metz, 57038, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298, France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, 44805, France
Centre Antoine Lacassagne
Nice, 06189, France
Hopital Europeen Georges Pompidou
Paris, 75015, France
Hopital Saint Michel
Paris, 75015, France
Institut Jean Godinot
Reims, 51056, France
Hopital Foch
Suresnes, 92151, France
Institut Claudius Regaud
Toulouse, 31052, France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, 37044, France
Institut Gustave Roussy
Villejuif, F-94805, France
Related Publications (2)
Cabarrou B, Boher JM, Bogart E, Tresch-Bruneel E, Penel N, Ravaud A, Escudier B, Mahier Ait-Oukhatar C, Delord JP, Roche H, Filleron T. How to report toxicity associated with targeted therapies? Ann Oncol. 2016 Aug;27(8):1633-8. doi: 10.1093/annonc/mdw218. Epub 2016 May 23.
PMID: 27217543DERIVEDRavaud A, Oudard S, De Fromont M, Chevreau C, Gravis G, Zanetta S, Theodore C, Jimenez M, Sevin E, Laguerre B, Rolland F, Ouali M, Culine S, Escudier B. First-line treatment with sunitinib for type 1 and type 2 locally advanced or metastatic papillary renal cell carcinoma: a phase II study (SUPAP) by the French Genitourinary Group (GETUG)dagger. Ann Oncol. 2015 Jun;26(6):1123-1128. doi: 10.1093/annonc/mdv149. Epub 2015 Mar 23.
PMID: 25802238DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
Alain Ravaud, MD, PhD
Hopital Saint Andre
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2007
First Posted
October 8, 2007
Study Start
September 5, 2007
Primary Completion
February 1, 2011
Study Completion
April 1, 2013
Last Updated
February 21, 2021
Record last verified: 2021-02