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

Kidney Cancer Clinical Trial

Official title:

Phase II of Sunitinib (SUTENT®) in First Line for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma - SUPAP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00541008
• Other study ID #: CDR0000569863
• Secondary ID: FRE-FNCLCC-GEP-0
• Status: Completed
• Phase: Phase 2
• Start date: September 5, 2007
• Est. completion date: April 2013

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2013
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

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:

Inclusion criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• sunitinib malate

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz	Besancon
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	CHU de la Timone	Marseille
France	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	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

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tumor response rate
Secondary	Safety
Secondary	Overall survival
Secondary	Time to disease progression
Secondary	Time to response
Secondary	Duration of response