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Collecting Duct Carcinoma (Kidney)Phase 2BEVABELNCT02363751

Study of Gemcitabine+Platinum Salt+Bevacizumab Combination for Metastatic Collecting Duct Carcinoma (GETUG-AFU 24)

A Phase 2 study testing Bevacizumab in people with Collecting Duct Carcinoma (Kidney), run by UNICANCER at 19 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

Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinum salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Collecting Duct Carcinoma (Kidney)
What is being tested?
Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
19 sitesFrance
Study dates
Dec 2014to Aug 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients should be aged ≥18 years at the inclusion,
  • Patients with histologically confirmed metastatic collecting duct carcinoma (medullary accepted),
  • Available tumor samples for centralized reading by anatomopathologist,
  • Patients with or without nephrectomy,
  • At least one measurable lesion as per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1),
  • No prior chemotherapy nor anti-angiogenic drugs ; Prior adjuvant chemotherapy of localised disease admitted if it is stopped for more than 12 months at the inclusion date.,
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  • No irradiation within 4 weeks before inclusion,
  • Absolute neutrophil counts (ANC) ≥1.5 x 10⁹/L,
  • Platelets ≥100 x 10⁹/L,
  • Hemoglobin ≥9 g/dL,
  • Hepatic function : AST and ALT ≤1.5 x ULN (≤4 x ULN in case of liver metastases); total bilirubin ≤1.5 x ULN; alkaline phosphatase <2 x ULN (≤4 x ULN in case of bone metastases),
  • Renal function : creatinine clearance ≥60 mL/min (MDRD calculation method) using cis-platin and >30 mL/min when using carboplatin,
  • Absence of proteinuria at baseline defined by <0.3 g of protein on urine sample or <0.5 g/24h on urine collection,
  • Prothrombin time (TP) or partial thromboplastin time (PTT) strictly less than 50% deviation from normal limits, of international normalized ratio (INR) strictly below 2, Note: The use of full-dose oral or parenteral anticoagulants as well as aspirin or clopidogrel is permitted as long as the INR or a PTT is within therapeutic limits (according to the medical standard of the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of study enrolment. Prophylactic use of anticoagulants is allowed.
  • ECG with normal or clinically insignificant as per investigator's judgement sinus rhythm,
  • ECOG Performance Status: 0 - 2,
  • Estimated life expectancy ≥12 weeks,
  • Patients who have received the information sheet, dated and signed the informed consent form,
  • Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 6 months after the last study treatment intake.
  • Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
  • Patients affiliated to the Social Security System,

Who cannot join

  • Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment,
  • Prior systemic treatment with chemotherapy or anti-angiogenic tyrosine kinase inhibitors such as axitinib, sunitinib, sorafenib, pazopanib, tivozanib, mTOR inhibitor (Temsirolimus or everolimus) and targeted VEGF drugs such as bevacizumab and VEGF trap,
  • Evidence of current spinal cord compression or leptomeningeal disease. Please note that patients with asymptomatic brain metastases are eligible,
  • Another histological type of renal cancer
  • Other malignancy within 3 years prior to inclusion (except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix, and/or pT1/a bladder cancer),
  • Uncontrolled hypertension (≥160 mm Hg systolic and/or ≥90 mm Hg diastolic) while receiving medication,
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  • Cardio-vascular disorders: congestive heart failure ≥ NYHA II, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina,
  • LVEF value strictly less than 50%,
  • Current or recent (within 2 weeks of study enrolment) initiation of aspirin, clopidogrel), oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes,
  • History of clinically significant hemorrhagic or thromboembolic events in the past six months, or known inherited predisposition to bleeding or thrombosis or History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment; History of haemoptysis ≥ grade 2 (defined as ≥2.5 mL bright red blood per episode) within 1 month of study enrolment,
  • Patients who underwent, according to the investigator, a significant surgery such as but not limited to , abdominal, thoracic or neurologic surgery within 28 days before the first treatment administration or patient with a wound that is not already healed at the first treatment administration or patients who underwent a minor surgical procedure including placement of a vascular access device, within 2 days of the first study treatment,
  • Patients with active gastro-duodenal ulcer,
  • Patients with untreated bone fracture,
  • Peripheral neuropathy grade ≥2 (Toxicity Criteria-(CTCAE) v4.0),
  • Patients with active infection requiring intravenous antibiotics at the time of first study treatment,
  • In the opinion of the investigator, any evidence of other severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or any other acute or chronic medical condition that would make the patient inappropriate with this study,
  • Immunocompromised patients, including known seropositivity for human immunodeficiency virus (HIV),
  • Known hypersensitivity to any component of the investigational drugs or excipients,
  • Pregnant or lactating women,
  • Person deprived of their liberty or under judicial protection (including guardianship),
  • Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial. Those conditions should be discussed with the patient before registration in the trial.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites

  • Institut de Cancérologie de l'Ouest-Site Paul Papin

    Angers, 49333

  • CHU Besançon

    Besançon, 25030

  • Hôpital Saint André

    Bordeaux, 33075

  • Centre François Baclesse

    Caen, 14076

  • Hôpital Henri Mondor

    Créteil, 94000

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Léon Bérard

    Lyon, 69008

  • Institut Paoli-Calmettes

    Marseille, 13273

  • ICM Val d'Aurelle

    Montpellier, 34298

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hôpital Saint-Louis

    Paris, 75010

  • Hôpital Européen Georges Pompidou

    Paris, 75908

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Eugene Marquis

    Rennes, 35064

  • Institut de cancérologie de l'Ouest - Site René Gauducheau

    Saint-Herblain, 44800

  • CHU Strasbourg - Hôpital Civil

    Strasbourg, 67091

  • Institut Claudius Regaud

    Toulouse, 31059

  • CHR Bretonneau

    Tours, 37044

  • Gustave Roussy, Cancer Campus, Grand Paris

    Villejuif, 94805

Other trials in France

About this study

Official title: Prospective Phase II Study of Gemcitabine Plus Platinum Salt in Combination With Bevacizumab (Avastin®) for Metastatic Collecting Duct Carcinoma

Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinum salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma.

Being tested
Bevacizumab
Keywords
Bellini, Metastatic, Chemotherapy, Bevacizumab
Medical subject headings
Carcinoma, Renal Cell, Neoplasm Metastasis

What participants receive

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

  • BevacizumabDrug

    Also called Avastin

    Patients will be treated for a maximum of 6 (21days) chemotherapy cycles (Gemcitabine+platinum salt+bevacizumab).

    In case of disease control (complete, partial or stable disease) treatment with bevacizumab 15 mg/Kg monotherapy every 21 days will be continued until disease progression or until the end of the 24 months of follow-up.

Study groups in NCT02363751
Study groupRoleWhat they receive
1ExperimentalPatients will be treated for a maximum of 6 (21 days) chemotherapy cycles (Gemcitabine+platinum salt+bevacizumab)
Receives: Drug: Bevacizumab

What is being measured

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

  1. Composite endpoint : Objective response rate / Progression-free survival

    The primary endpoint is composed of:

    • the objective response rate (CR or PR) according to RECIST criteria (V1.1) on the basis of measurable lesions defined at baseline,
    • the progression-free survival (PFS) rate at 6 months , PFS is defined as the absence of disease progression or death

    Measured: 6 months

Secondary outcomes (3)

  1. Progression-free survival (PFS)

    Progression-free survival (PFS) will be calculated from the date of the first dose of treatment to the date of progression or death (whichever comes first), or last date with no progression

    Measured: 2 years max

  2. The Overall Survival (OS)

    The Overall Survival (OS) will be calculated from the date of the first dose of treatment to the date of death (whatever the cause) or the date of last follow-up

    Measured: 2 years max

  3. The toxicity will be evaluated according to the NCI-CTC scale version 4.0

    Measured: 2 years max

Timeline

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

  1. First posted16 Feb 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionMar 2020
  4. Study completionAug 2020

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02363751
Sponsor's protocol ID
UC-0160/1210
Other IDs
2013-001179-19
Acronym
BEVABEL
Status last verified
Mar 2021
First submitted
9 Feb 2015
Last updated
9 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Thibault C, Flechon A, Albiges L, Joly C, Barthelemy P, Gross-Goupil M, Chevreau C, Coquan E, Rolland F, Laguerre B, Gravis G, Pecuchet N, Elaidi RT, Timsit MO, Brihoum M, Auclin E, de Reynies A, Allory Y, Oudard S. Gemcitabine plus platinum-based chemotherapy in combination with bevacizumab for kidney metastatic collecting duct and medullary carcinomas: Results of a prospective phase II trial (BEVABEL-GETUG/AFU24). Eur J Cancer. 2023 Jun;186:83-90. doi: 10.1016/j.ejca.2023.03.018. Epub 2023 Mar 23.

    PubMed 37054556

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab in people with Collecting Duct Carcinoma (Kidney), run by UNICANCER at 19 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 21 inclusion and 21 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 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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?

Composite endpoint : Objective response rate / Progression-free survival (time frame: 6 months). 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 NCT02363751, which also lists 1 linked publication.

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 9 Mar 2021.

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