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

February 18, 2021 updated by: UNICANCER

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49036
        • Centre Paul Papin
      • Besancon, France, 25030
        • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
      • Bordeaux, France, 33075
        • Hopital Saint Andre
      • Brest, France, 29609
        • C.H.U. de Brest
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Grenoble, France, 38043
        • CHU de Grenoble - Hopital de la Tronche
      • La Roche Sur Yon, France, 85025
        • Centre Hospitalier departemental
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69373
        • Centre Leon Berard
      • Marseille, France, 13385
        • CHU de la Timone
      • Marseille, France, 13273
        • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
      • Metz, France, 57038
        • Hopital Notre-Dame de Bon Secours
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Nantes-Saint Herblain, France, 44805
        • CRLCC Nantes - Atlantique
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75015
        • Hopital Saint Michel
      • Reims, France, 51056
        • Institut Jean Godinot
      • Suresnes, France, 92151
        • Hopital Foch
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Tours, France, 37044
        • Centre Hospitalier Universitaire Bretonneau de Tours
      • Villejuif, France, F-94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Objective tumor response rate

Secondary Outcome Measures

Outcome Measure
Overall survival
Time to disease progression
Safety
Duration of response
Time to response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Alain Ravaud, MD, PhD, Hopital Saint Andre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 5, 2007

First Posted (Estimate)

October 8, 2007

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000569863
  • FRE-FNCLCC-GEP-03-0603
  • EU-20761
  • EUDRACT-2006-003339-62
  • PFIZER-FRE-FNCLCC-GEP-03-0603

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Cancer

Clinical Trials on sunitinib malate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe