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Advanced Urothelial CancerPhase 2/3VEFORANCT02240017

A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function.

A Phase 2/3 study testing Carboplatin, Fractionated Cisplatin and Gemcitabine in people with Advanced Urothelial Cancer and Metastatic Urothelial Cancer, run by Institut Claudius Regaud at 18 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

This is a phase II/III, multicenter, randomized study which includes 420 patients on six years + 3 years follow up. 92 patients will be included during the phase II ; additional 328 patients will be included. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Fractionated Cisplatin and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
18 sitesFrance
Study dates
21 Jan 2015to 15 Jul 2019
Phase
Phase 2/3
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

  • . Age < or = 18 years, patients aged 75 years or more will benefit from a geriatric assessment.
  • . Advanced or metastatic urothelial cancer confirmed histologically or cytologically.
  • . Patients liable to receive a first -line chemotherapy for advanced or metastatic urothelial carcinoma.
  • . Measurable disease according to RECIST criteria V1.1.
  • . Patients who received neoadjuvant or adjuvant chemotherapy based on platinum salt must have completed treatment at least 6 months before entering the study.
  • . Performance status < or = 2.
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  • . Life expectancy > 3 months.
  • . Patients with creatinine clearance between 40 and 60 ml / min ( according to Cockcroft and Gault ).
  • . Patients having no contra-indication to overhydration.
  • . Satisfactory hematological tests: Neutrophils > 1.5 G / l Platelets > 150 G / l , hemoglobin ≥ 10 g / dl.
  • . Satisfactory liver function tests: total bilirubin < 1.5 x ULN (upper limit of normal), AST (aspartate aminotransferase) and ALT (alanine aminotransferase)<or = 2.5 x ULN (or 5 x ULN if liver metastases).
  • . In case of prior radiotherapy, a minimum of 14 days must relapse between the end of radiotherapy and study entry.
  • . For women of childbearing age , use an effective contraceptive method to study entry and for the duration of the study and 6 months after the last dose of study treatment ; For sexually active fertile men having a partner of childbearing age using effective contraception for the duration of the study and 6 months after the last dose of study treatment.
  • . Patient affiliated to a social security system in France.
  • . Patient signed informed consent before inclusion in the study and before any specific procedure for the study.

Who cannot join

  • . Any concomitant or previous malignancy within 5 years prior to the study ( with the exception of basal cell or squamous cell carcinoma in situ).
  • . Pregnant or lactating women.
  • . Patients with brain metastases or meningeal or symptoms suggestive of such secondary locations.
  • . Bisphosphonate or Denosumab treatment initiated within 28 days prior to randomization into the study or patient who have started such treatment during the study ( a bisphosphonate or denosumab treatment initiated within a period longer than 28 days before randomization may be continued without change during the study ).
  • . Other concomitant cancer (radiation therapy, radiopharmaceutical agent chemotherapy).
  • . Patients with uncontrolled infection.
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  • . Patients with peripheral neuropathy grade> 1, whatever the origin or patients with hearing loss.
  • . Patient with unstable disease (eg: unstable diabetes, poorly controlled hypertension , congestive heart failure or myocardial infarction within 3 months prior to study entry).
  • . Known hypersensitivity to study drugs.
  • . Treatment with any other investigational drug within 30 days before inclusion.
  • . Any psychological condition , familial, sociological or geographical not to comply with medical monitoring and / or procedures in the study protocol.
  • . Patient protected by law.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Paul Papin

    Angers, 49933

  • Chru Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Francois Baclesse

    Caen, 14076

  • Centre Georges Francois Leclerc

    Dijon, 21079

  • CH VERSAILLES - Hôpital André Mignot

    Le Chesnay, 78157

  • CHU LIMOGES - Hôpital Dupuytren

    Limoges, 87042

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13273

  • Ch Mont de Marsan

    Mont-de-Marsan, 40024

  • Institut Regional Du Cancer Montpellier

    Montpellier, 34298

  • Ap-Hp-Hopital Saint-Louis

    Paris, 75010

  • INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau

    Saint-Herblain, 44805

  • Institut de Cancerologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271

  • CHU de STRASBOURG

    Strasbourg, 67091

  • Institut Claudius Regaud

    Toulouse, 31052

  • Chru Tours

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: Randomized, Multicenter, Phase II/III Study, Evaluating Fractionated Cisplatin Chemotherapy/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function.

This is a phase II/III, multicenter, randomized study which includes 420 patients on six years + 3 years follow up. 92 patients will be included during the phase II ; additional 328 patients will be included.

Patients with an advanced or metastatic urothelial cancer with impaired renal function will be randomized in one of the two following chemotherapy arm:

Read more
  • Fractionated Cisplatin + Gemcitabine.
  • Carboplatin + Gemcitabine.

The main objective of the part II study will be to evaluate the efficacy and the safety of a chemotherapy with a doublet platinum salt compound/Gemcitabine with fractionated Cisplatin or Carboplatin in this population.

The main objective of the part III study will be to compare the efficacy in terms of overall survival of a chemotherapy with a doublet platinum salt/Gemcitabine with fractionated Cisplatin or Carboplatin in this population.

Being tested
Carboplatin, Fractionated Cisplatin, Gemcitabine
Keywords
Urothelial cancer, renal function impaired.

What participants receive

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

  • CarboplatinDrug

    Carboplatin AUC (area under curve) 4,5 at day 1 of each cycle until 6 cycles.

  • Fractionated CisplatinDrug

    Cisplatin 35mg/m² at day 1 and day 8 of each cycle until 6 cycles.

  • GemcitabineDrug

    Gemcitabine 1000mg/m² at day 1 and day 8 of each cycle until 6 cycles.

Study groups in NCT02240017
Study groupRoleWhat they receive
Carboplatin/GemcitabineActive comparatorNot described
Receives: Drug: Carboplatin; Drug: Gemcitabine
Fractionated Cisplatin/GemcitabineExperimentalNot described
Receives: Drug: Fractionated Cisplatin; Drug: Gemcitabine

What is being measured

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

  1. Phase II: Efficacy - Rate of non progression at the end of treatment (C6D21).

    Progression is defined according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria V1.1.

    Measured: 5 years.

  2. Phase III: Overall survival (in months).

    Overall survival is defined as the time from randomization until death or last follow up news (censured data).

    Measured: 9 years.

  3. Phase II: Tolerance - Percentage of patients for whom at least one of the 3 defined tolerance criteria (see description) is observed.

    Defined tolerance criteria :

    • Postponement of chemotherapy > or = 2 weeks.
    • Alteration of renal function.
    • Need to decrease twice Gemcitabine dose on day 1 for : NCI CTC (National Cancer Institut Common Toxicity Criteria) grade III or IV non-hematologic toxicity, hematologic toxicity.

    Measured: 5 years.

Secondary outcomes (9)

  1. Phase II and III: Objective response.

    Objective response (ie complete or partial response) will be evaluated according to RECIST v1.1 criteria.

    Measured: Phase II: 5 years ; Phase III: 9 years.

  2. Phase II and III: Tolerance according to NCI toxicity scale (version 4.0).

    Measured: Phase II: 5 years ; Phase III: 9 years.

  3. Phase II and III: Geriatric evaluation using questionnaires.

    The geriatric assessment will be evaluate using the following questionnaires: G8 (oncodage) , ADL (activity of daily living), CIRSG (cumulating illness rating scale geriatric) , MMS (mini-mental score), IADL (instrumental activities of daily living), GDS (geriatric depression scale), MNA (mini-nutritional assessment).

    Measured: Phase II: 5 years ; Phase III: 9 years.

  4. Phase II and III: Quality of life using the EORTC QLQ - C30 questionnaire (European Organization for research and treatment of Cancer - Quality of life questionnaire).

    Measured: Phase II: 5 years ; Phase III: 9 years.

  5. Phase II and III: Pharmacokinetics - Platin concentrations

    Measured: At cycles 1 and 2 day 1 - 5 mn before the end of infusion, one hour after the end of infusion, 3 hours (arm A) or 4 hours (arm B) after the end of infusion.

  6. Phase II and III: Pharmacogenetics, exploration of cytidine deaminase activity and study of its genetic polymorphisms.

    Measured: Prior to the initial dose on cycle 1 day 1.

  7. Phase II and III: Progression free survival.

    Progression free survival will be evaluated according to RECIST v1.1 criteria.

    Measured: Phase II: 5 years ; phase III: 9 years.

  8. Phase II and III: Overall survival.

    Overall survival is defined as the time from randomization until death from all causes combined.

    Measured: Phase II: 5 years ; Phase III: 9 years.

  9. Phase II and III: Time to treatment failure.

    Time to treatment failure is defined as the time from randomization to treatment discontinuation, whatever its cause.

    Measured: Phase II: 5 years ; Phase III: 9 years.

Timeline

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

  1. First posted15 Sep 2014 (estimated)
  2. Study start21 Jan 2015
  3. Primary completion10 Apr 2018
  4. Study completion15 Jul 2019

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02240017
Sponsor's protocol ID
13 URO 02
Acronym
VEFORA
Status last verified
Aug 2019
First submitted
5 Sep 2014
Last updated
9 Aug 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Carboplatin, Fractionated Cisplatin and Gemcitabine in people with Advanced Urothelial Cancer and Metastatic Urothelial Cancer, run by Institut Claudius Regaud at 18 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 15 inclusion and 12 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 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Phase II: Efficacy - Rate of non progression at the end of treatment (C6D21). (time frame: 5 years.). The study lists 3 primary outcomes in all. 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 NCT02240017.

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 Aug 2019.

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