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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00541008
First received: October 5, 2007
Last updated: August 13, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: sunitinib malate
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II of Sunitinib (SUTENT®) in First Line for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma - SUPAP

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective tumor response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Time to response [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]

Estimated Enrollment: 92
Study Start Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541008

Locations
France
Centre Paul Papin Recruiting
Angers, France, 49036
Contact: Sophie Abadie-Lacourtoisie, MD    33-2-4135-2734      
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Ulrich Stein, MD    33-3-8166-8240      
Hopital Saint Andre Recruiting
Bordeaux, France, 33075
Contact: Alain Ravaud, MD, PhD    33-5-5679-5808    alain.ravaud@chu-bordeaux.fr   
C.H.U. de Brest Recruiting
Brest, France, 29609
Contact: Jean-Pierre Malhaire, MD    33-2-9822-3395      
Centre Regional Francois Baclesse Recruiting
Caen, France, 14076
Contact: Emmanuel Sevin, MD    33-2-3145-5017    e.sevin@baclesse.fr   
CHU de Grenoble - Hopital de la Tronche Recruiting
Grenoble, France, 38043
Contact: Matthieu Laramas, MD    33-4-7676-5333      
Centre Hospitalier Departemental Recruiting
La Roche Sur Yon, France, 85025
Contact: Franck Priou, MD    33-2-5144-6173    frank.priou@chd-vendee.fr   
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Armelle Caty, MD    33-3-2029-5942    acaty@o-lambret.fr   
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Sylvie Negrier, MD    33-4-7878-2751    negrier@lyon.fnclcc.fr   
CHU de la Timone Recruiting
Marseille, France, 13385
Contact: Marjorie Baciuchka-Palmaro    33-91-385-708      
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Recruiting
Marseille, France, 13273
Contact: Gwenaelle Gravis, MD    33-4-9122-3740    gravisg@marseille.fnclcc.fr   
Hopital Notre-Dame de Bon Secours Recruiting
Metz, France, 57038
Contact: Sabine Walter, MD    33-387-553-554    s.walter@chr-metz-thionville.rss.fr   
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Stephane Culine, MD    33-4-6761-8555    stculine@valdorel.fnclcc.fr   
CRLCC Nantes - Atlantique Recruiting
Nantes-Saint Herblain, France, 44805
Contact: Frederic Rolland, MD    33-2-40-67-99-76    F-rolland@nantes.fnclcc.fr   
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Jean Marc Ferrero, MD    33-4-9203-1511    jean-marc.ferrerero@nice.fnclcc.fr   
Hopital Europeen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Stephane Oudard, MD, PhD    33-1-5609-3434    stephane.oudard@hop.egp.ap-hop-paris.fr   
Hopital Saint Michel Recruiting
Paris, France, 75015
Contact: Gael Deplanque, MD, MSC, PhD    33-1-4412-3078      
Institut Jean Godinot Recruiting
Reims, France, 51056
Contact: Herve Cure, MD, PhD    33-3-2650-4382      
Hopital Foch Recruiting
Suresnes, France, 92151
Contact: Christine Theodore, MD    33-1-4625-2149      
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Christine Chevreau-Dalbianco, MD    33-5-6142-4118    chevreau.christine@claudiusregaud.fr   
Centre Hospitalier Universitaire Bretonneau de Tours Recruiting
Tours, France, 37044
Contact: Claude Linassier, MD, PhD    33-2-4747-3827    linassier@med.univ-tours.fr   
Institut Gustave Roussy Recruiting
Villejuif, France, F-94805
Contact: Bernard Escudier, MD    33-1-4211-5410    escudier@igr.fr   
Sponsors and Collaborators
UNICANCER
Investigators
Investigator: Alain Ravaud, MD, PhD Hopital Saint Andre
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00541008     History of Changes
Other Study ID Numbers: CDR0000569863, FRE-FNCLCC-GEP-03-0603, EU-20761, EUDRACT-2006-003339-62, PFIZER-FRE-FNCLCC-GEP-03-0603
Study First Received: October 5, 2007
Last Updated: August 13, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
type 1 papillary renal cell carcinoma
type 2 papillary renal cell carcinoma
stage IV renal cell cancer
stage III renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 11, 2014