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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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
Angers, France, 49036
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Hopital Saint Andre
Bordeaux, France, 33075
C.H.U. de Brest
Brest, France, 29609
Centre Regional Francois Baclesse
Caen, France, 14076
CHU de Grenoble - Hopital de la Tronche
Grenoble, France, 38043
Centre Hospitalier Departemental
La Roche Sur Yon, France, 85025
Centre Oscar Lambret
Lille, France, 59020
Centre Leon Berard
Lyon, France, 69373
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
CHU de la Timone
Marseille, France, 13385
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Saint Michel
Paris, France, 75015
Institut Jean Godinot
Reims, France, 51056
Hopital Foch
Suresnes, France, 92151
Institut Claudius Regaud
Toulouse, France, 31052
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, France, 37044
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
UNICANCER
Investigators
OverallOfficial: Alain Ravaud, MD, PhD Hopital Saint Andre
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on December 05, 2016