Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer

NCT ID: NCT00541008

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-05
• Study Completion Date: 2013-04-30

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.

Detailed Description

OBJECTIVES:

Primary

• To determine the objective tumor response rate in patients with locally advanced or metastatic papillary renal cell carcinoma treated with sunitinib malate.

Secondary

• To evaluate the safety of this drug in these patients.
• To determine time-to-event variables of overall survival, time to disease progression, time to response, and duration of response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once a day on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 28 days and then periodically thereafter.

Conditions

Kidney Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

sunitinib malate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• INR ≤ 1.7 or PT ≤ 6 seconds over ULN
• Not pregnant or nursing
• Fertile patients must use effective contraception
• Patients must be affiliated to a Social Security System
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria

• 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
• Inability to swallow oral medications or presence of active inflammatory bowel disease, partial or complete bowel obstruction, or chronic diarrhea
• Known HIV or AIDS infection
• Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration
• Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and the follow-up schedule
• Patients deprived of liberty or placed under the authority of a tutor

PRIOR CONCURRENT THERAPY:

• Recovered from all toxic effects of any prior local treatment to CTCAE version 3.0 grade ≤ 1
• At least 4 weeks since prior radiotherapy

• At least 1 week since prior radiotherapy to < 10% of the whole body allowed provided side effects are < grade 2 and there is at least one site for evaluation
• More than 2 weeks since prior and no concurrent anticoagulant agents or therapeutic doses of warfarin

• Low-dose warfarin (up to 2 mg/day) for deep vein thrombosis prophylaxis allowed
• Low molecular weight heparin allowed
• No prior specific medical systemic therapy (i.e., first-line therapy)
• No prior sunitinib malate
• No prior investigational agents
• No concurrent treatment on another therapeutic clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain Ravaud, MD, PhD

Role:

Hopital Saint Andre

Locations

Centre Paul Papin

Angers, , France

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, , France

Hopital Saint Andre

Bordeaux, , France

C.H.U. de Brest

Brest, , France

Centre Regional Francois Baclesse

Caen, , France

CHU de Grenoble - Hopital de la Tronche

Grenoble, , France

Centre Hospitalier Departemental

La Roche-sur-Yon, , France

Centre Oscar Lambret

Lille, , France

Centre Leon Berard

Lyon, , France

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, , France

CHU de la Timone

Marseille, , France

Hopital Notre-Dame de Bon Secours

Metz, , France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, , France

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, , France

Centre Antoine Lacassagne

Nice, , France

Hopital Europeen Georges Pompidou

Paris, , France

Hopital Saint Michel

Paris, , France

Institut Jean Godinot

Reims, , France

Hopital Foch

Suresnes, , France

Institut Claudius Regaud

Toulouse, , France

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 27217543 (View on PubMed)

Ravaud 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.

Reference Type: DERIVED

PMID: 25802238 (View on PubMed)

Other Identifiers

FRE-FNCLCC-GEP-03-0603

Identifier Type: -

Identifier Source: secondary_id

EU-20761

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2006-003339-62

Identifier Type: -

Identifier Source: secondary_id

PFIZER-FRE-FNCLCC-GEP-03-0603

Identifier Type: -

Identifier Source: secondary_id

CDR0000569863

Identifier Type: -

Identifier Source: org_study_id