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AzTrials

Recurrent Bladder CancerPhase 2CVH-CT02NCT01828736

Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma

A Phase 2 study testing Trastuzumab, Gemcitabine and Carboplatin in people with Recurrent Bladder Cancer and Stage IV Bladder Cancer, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 15 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of association of trastuzumab with combination chemotherapy in advanced or metastatic bladder cancer patients. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Trastuzumab, Gemcitabine and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
15 sitesin 2 countries
Study dates
9 Feb 2004to 23 Feb 2010
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Transitional cell carcinoma of the urothelium or bladder histologically proven stage IV AJCC [locally advanced (T4b and / or N + M0) unresectable or metastatic (M1)]
  • Tumor and / or metastasis overexpressing HER2 immunohistochemistry (IHC 3 +) or IHC 2 + and FISH +. Centralized analysis.
  • Measurable disease with at least one lesion with a diameter> 2 cm for conventional methods (clinical examination, CT or MRI) or> 1 cm for the helical scanner. In case of single metastasis, metastatic disease should be histologically proven
  • Age ≥ 18 years and ≤80 years
  • Life expectancy> 3 months,
  • Index performance status <2 according to ECOG PS,
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  • No prior chemotherapy other than adjuvant and / or neoadjuvant chemotherapy, without Herceptin ® and complete for more than 6 months (naive to any previous chemotherapy in the metastatic setting)
  • No radiotherapy within 4 weeks prior to inclusion,
  • Normal cardiac function as measured by ejection fraction (LVEF> 50%),
  • Blood and liver satisfactory constants:
  • Hematological criteria: - Neutrophils> 1.5 x 109 / L, - Chips> 100 x 109 / L - Hemoglobin> 10 g / dL, Liver function: - Alkaline phosphatase (unless bone metastases) <2 x N - Total bilirubin <1.5 x N - transaminases (AST, ALT) <1.5 x N, renal Constants: - Creatinine clearance > 30 ml / min (Cockcroft and Gault, cf. Annex XV protocol)
  • Patient's written consent after full information.

Who cannot join

  • Concurrent treatment with an experimental drug, participation in another clinical trial within <30 days
  • Patients previously treated with Herceptin ®, or another treatment targeting growth factors EGF (eg Iressa ®, Tarceva ®)
  • Existence of a severe pulmonary disease, liver or kidney is likely to be exacerbated by the treatment,
  • Other medical conditions: congestive heart failure or angina pectoris even if medically controlled failure, history of myocardial infarction before entering the trial, hypertension or uncontrolled arrhythmias, significant valvular disease,
  • Patient with dyspnoea at rest or requiring oxygen therapy or with respiratory failure,
  • Presence of a severe infection requiring antibiotics,
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  • Presence of CNS metastases or meningeal
  • History of another malignancy uncured or cured for less than 5 years (except basal cell carcinoma, papillary thyroid carcinoma in situ of the cervix treated)
  • Pregnant or lactating or not using effective contraception Women,
  • For Cisplatin only: carrying a serious neurological disease, current events devices> NCI grade 2 neuropathy, hearing loss, creatinine clearance <60 ml / min, the patient can not support a patient hydration.

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

France14 sites

  • CHU de Besançon

    Besançon, 25000

  • CHU Hôpital Saint André

    Bordeaux, 33000

  • Hôpital Jean Perrin

    Clermont-Ferrand, 63000

  • Centre Hospitalier Départemental de la Vendée

    La Roche-sur-Yon, 85000

  • Clinique Victor Hugo

    Le Mans, 72000

  • CHU Hôpital La Timone

    Marseille, 13005

  • Institut Paoli Calmettes

    Marseille, 13009

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200

  • Curie Institute

    Paris, 75005

  • Hôpital Saint Louis

    Paris, 75010

  • Groupe Hospitalier Saint Joseph Paris

    Paris, 75014

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Hôpital Foch

    Suresnes, 92151

Other trials in France

Belgium1 site

  • Cliniques saint Luc - Université Catholique de Louvain

    Brussels, 1200

Other trials in Belgium

About this study

Official title: Multicenter Randomized Phase 2 Trial of Gemcitabine - Platinum With or Without Trastuzumab in Advanced or Metastatic Urothelial Carcinoma With HER2 Overexpression

A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of association of trastuzumab with combination chemotherapy in advanced or metastatic bladder cancer patients. Combining monoclonal antibody therapy with combination chemotherapy may improve treatment efficacy on tumours overexpressed HER 2.

Keywords
Urothelial carcinoma, Trastuzumab, Treatment
Medical subject headings
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell

What participants receive

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

  • TrastuzumabBiological

    Also called anti-c-erB-2, Herceptin, MOAB HER2

    Bottles of 150 mg; Charging dose: 8mg/kg then 6mg/kg every 21 days given IV

  • GemcitabineDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, Gemzar, gemcitabin hydrochloride

    Given IV, 1000 mg/m² BSA on Day 1 and Day 8 every 21 days

  • CarboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV: AUC 5 on Day 1 every 21 days

  • CisplatinDrug

    Also called cis-Diamminedichloroplatinum(II), Platinum Diamminodichloride, Diamminodichloride, Platinum, cis-Platinum

    Given IV, 70 mg/m² BSA on day 1 every 21 days

Study groups in NCT01828736
Study groupRoleWhat they receive
Arm A: Platinum + GemcitabineActive comparatorGemcitabine = 1 000 mg/m2 Day1 and Day8 given every 21 days IV + If Creatinin Clearance > 60 ml/min : Cisplatin = Day 1: 70 mg/m² given every 21 days If Creatinin Clearance < 60 ml/min : Carboplatin = Day 1: AUC 5 given every 21 days
Receives: Drug: Gemcitabine; Drug: Carboplatin; Drug: Cisplatin
Arm B: Platinum+Gemcitabine+TrastuzumabExperimentalTrastuzumab: Charging dose = 8mg/kg on day 1; then 6mg/kg every 21 days given IV + Gemcitabine = 1 000 mg/m2 Day1 and Day8 given every 21 days IV + If Creatinin Clearance > 60 ml/min : Cisplatin = Day 1: 70 mg/m² given every 21 days If Creatinin Clearance < 60 ml/min : Carboplatin = Day 1: AUC 5 given every 21 days
Receives: Biological: Trastuzumab; Drug: Gemcitabine; Drug: Carboplatin; Drug: Cisplatin

What is being measured

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

  1. Progression Free survival

    Measured: Participants will be followed from radomization until progression or death, up to 3 years

Secondary outcomes (4)

  1. Objective response rate

    Measured: Objective Response Rate will be assessed during treatment period, every 3 cycles, up to 7 months

  2. Number of participants with adverse events as a measure of safety and tolerability

    Toxicity will be classify according to NCI-CTC criteria Version 2.0. Cardiac toxicity will be assessed according to the NYHA (New York Heart Association) criteria.

    Measured: Participants will be followed all along the study period, an expected average of 3 years

  3. Quality of life

    Quality of Life will be assessed according to the EORTC QLQ-C30 Version 3 questionnaire

    Measured: Quality of Life will be assessed during the study period, every 3 cycles (Arm A patients) or every 3 months (Arm B patients), up to 3 years

  4. Overall survival

    Measured: Participants will be followed from randomization until death or lost of follow-up, up to 3 years

Timeline

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

  1. First posted11 Apr 2013 (estimated)
  2. Study start9 Feb 2004
  3. Primary completion23 Feb 2010
  4. Study completion23 Feb 2010

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01828736
Sponsor's protocol ID
CVH-CT 02
Acronym
CVH-CT02
Status last verified
Feb 2017
First submitted
4 Apr 2013
Last updated
6 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • Oudard S, Culine S, Vano Y, Goldwasser F, Theodore C, Nguyen T, Voog E, Banu E, Vieillefond A, Priou F, Deplanque G, Gravis G, Ravaud A, Vannetzel JM, Machiels JP, Muracciole X, Pichon MF, Bay JO, Elaidi R, Teghom C, Radvanyi F, Beuzeboc P. Multicentre randomised phase II trial of gemcitabine+platinum, with or without trastuzumab, in advanced or metastatic urothelial carcinoma overexpressing Her2. Eur J Cancer. 2015 Jan;51(1):45-54. doi: 10.1016/j.ejca.2014.10.009. Epub 2014 Nov 15.

    PubMed 25459391

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab, Gemcitabine and Carboplatin in people with Recurrent Bladder Cancer and Stage IV Bladder Cancer, run by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie at 15 sites in 2 countries.

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 12 inclusion and 10 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 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France, Belgium. 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?

Progression Free survival (time frame: Participants will be followed from radomization until progression or death, up to 3 years). 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 NCT01828736, 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 6 Feb 2017.

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