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AzTrials

Kidney CancerPhase 2NCT00541008

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

A Phase 2 study testing sunitinib malate in people with Kidney Cancer, run by UNICANCER at 22 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Kidney Cancer
What is being tested?
sunitinib malate
How many people
92 participants
Where
22 sitesFrance
Study dates
5 Sep 2007to Apr 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • PATIENT CHARACTERISTICS:
  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

France22 sites

  • Centre Paul Papin

    Angers, 49036

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Saint Andre

    Bordeaux, 33075

  • C.H.U. de Brest

    Brest, 29609

  • Centre Regional Francois Baclesse

    Caen, 14076

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, 85025

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • CHU de la Timone

    Marseille, 13385

  • Hopital Notre-Dame de Bon Secours

    Metz, 57038

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Saint Michel

    Paris, 75015

  • Institut Jean Godinot

    Reims, 51056

  • Hopital Foch

    Suresnes, 92151

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Kidney Cancer
Being tested
sunitinib malate
Keywords
type 1 papillary renal cell carcinoma, type 2 papillary renal cell carcinoma, stage IV renal cell cancer, stage III renal cell cancer
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sunitinib malateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective tumor response rate

Secondary outcomes (5)

  1. Safety

  2. Overall survival

  3. Time to disease progression

  4. Time to response

  5. Duration of response

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2007 (estimated)
  2. Study start5 Sep 2007
  3. Primary completionFeb 2011
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00541008
Sponsor's protocol ID
CDR0000569863
Other IDs
FRE-FNCLCC-GEP-03-0603, EU-20761, EUDRACT-2006-003339-62, PFIZER-FRE-FNCLCC-GEP-03-0603
Status last verified
Feb 2021
First submitted
5 Oct 2007
Last updated
21 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cabarrou B, Boher JM, Bogart E, Tresch-Bruneel E, Penel N, Ravaud A, Escudier B, Mahier Ait-Oukhatar C, Delord JP, Roche H, Filleron T. How to report toxicity associated with targeted therapies? Ann Oncol. 2016 Aug;27(8):1633-8. doi: 10.1093/annonc/mdw218. Epub 2016 May 23.

    PubMed 27217543

  • Ravaud A, Oudard S, De Fromont M, Chevreau C, Gravis G, Zanetta S, Theodore C, Jimenez M, Sevin E, Laguerre B, Rolland F, Ouali M, Culine S, Escudier B. First-line treatment with sunitinib for type 1 and type 2 locally advanced or metastatic papillary renal cell carcinoma: a phase II study (SUPAP) by the French Genitourinary Group (GETUG)dagger. Ann Oncol. 2015 Jun;26(6):1123-1128. doi: 10.1093/annonc/mdv149. Epub 2015 Mar 23.

    PubMed 25802238

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sunitinib malate in people with Kidney Cancer, run by UNICANCER at 22 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective tumor response rate. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00541008, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.

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