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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00541008
Recruitment Status : Unknown
Verified August 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : October 8, 2007
Last Update Posted : August 16, 2011
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: sunitinib malate Phase 2

Detailed Description:



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


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Masking: None (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
Study Start Date : September 2007

Primary Outcome Measures :
  1. Objective tumor response rate

Secondary Outcome Measures :
  1. Safety
  2. Overall survival
  3. Time to disease progression
  4. Time to response
  5. Duration of response

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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


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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00541008

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   
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   
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   
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Armelle Caty, MD    33-3-2029-5942   
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Sylvie Negrier, MD    33-4-7878-2751   
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Recruiting
Marseille, France, 13273
Contact: Gwenaelle Gravis, MD    33-4-9122-3740   
CHU de la Timone Recruiting
Marseille, France, 13385
Contact: Marjorie Baciuchka-Palmaro    33-91-385-708      
Hopital Notre-Dame de Bon Secours Recruiting
Metz, France, 57038
Contact: Sabine Walter, MD    33-387-553-554   
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Stephane Culine, MD    33-4-6761-8555   
CRLCC Nantes - Atlantique Recruiting
Nantes-Saint Herblain, France, 44805
Contact: Frederic Rolland, MD    33-2-40-67-99-76   
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Jean Marc Ferrero, MD    33-4-9203-1511   
Hopital Europeen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Stephane Oudard, MD, PhD    33-1-5609-3434   
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   
Centre Hospitalier Universitaire Bretonneau de Tours Recruiting
Tours, France, 37044
Contact: Claude Linassier, MD, PhD    33-2-4747-3827   
Institut Gustave Roussy Recruiting
Villejuif, France, F-94805
Contact: Bernard Escudier, MD    33-1-4211-5410   
Sponsors and Collaborators
OverallOfficial: Alain Ravaud, MD, PhD Hopital Saint Andre

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00541008     History of Changes
Other Study ID Numbers: CDR0000569863
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: August 16, 2011
Last Verified: August 2011

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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors