Infiltrating Urothelial CarcinomaPhase 3GETUG-AFU19NCT02818725
I-MVAC +/- Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma Without H-Ras Nor K-Ras Mutations
A Phase 3 study testing Chemotherapy and Panitumumab in people with Infiltrating Urothelial Carcinoma and KRAS Gene Mutation, run by UNICANCER at 17 sites in France.
Trial summary
OBJECTIVES OF THE TRIAL Primary objective Evaluation of efficacy in terms of progression-free survival at 9 months of the combination of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without Harvey nor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infiltrating Urothelial Carcinoma, KRAS Gene Mutation
- What is being tested?
- Chemotherapy and Panitumumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 17 sitesFrance
- Study dates
- Jun 2010to Sep 2017
- Phase
- Phase 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
- Primary tumour of the bladder or upper urinary tract
- Histologically confirmed infiltrating urothelial carcinoma (epidermoid and/or glandular forms are accepted)
- Patients without Harvey and Kirsten-rat sarcoma viral oncogene homolog mutations
- Advanced disease defined by a locally advanced stage (T4 and/or N+) ineligible for surgical resection, or a metastatic stage (M1)
- Patients with at least 1 evaluable lesion as per Response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
- 18 ≤ age ≤ 75 years
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- General condition 0 or 1 as per the WHO scale
- Absence of previous chemotherapy for advanced disease (chemotherapy with gemcitabine and platinum salt delivered as an adjuvant is accepted if this ended more than a year ago)
- Haematological function: Haemoglobin >11 g/dl, neutrophils ≥1500/mm³, platelets ≥100,000/mm³
- Liver function: Grade* 0 Aspartate aminotransferase and Alanine aminotransferase (< grade* 3 for liver metastases), grade* 0 alkaline phosphatases, normal bilirubin
- Renal function: calculated (or measured) creatinine clearance >60 ml/min
- Patients covered by a social security scheme
- Patient having read the information sheet and signed the informed consent form.
Who cannot join
- Pure adenocarcinoma or pure epidermoid carcinoma or mixed or pure small-cell neuroendocrine carcinoma
- Previous treatment with one of the following molecules: methotrexate, vinblastine, doxorubicin or Epidermal Growth Factor inhibitor
- History of interstitial pneumonitis or pulmonary fibrosis
- History of cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled serious cardiac arrhythmia) in the year prior to randomisation (≤1 year)
- Ventricular ejection fraction <50%
- Blood calcium and/or magnesium ≥ grade* 1
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- History of cancer in the 5 years prior to entry in the trial other than basal cell skin cancer or in situ epithelioma of the cervix,
- Treatment with radiotherapy for analgesic purposes (unless treatment was discontinued at least 15 days prior to inclusion in the trial)
- Potential allergy to panitumumab
- Male or female patients not agreeing to use an effective method of contraception throughout the duration of treatment and for 6 months after treatment discontinuation
- Pregnant women, or female subjects liable to become pregnant or currently breast-feeding,
- Patient already included in another therapeutic trial on an investigational medicinal product,
- Persons deprived of their freedom or under judicial protection (including guardianship),
- Unable to receive medical follow-up during the trial owing to geographical, social or psychological reasons.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Hopital Saint Andre
Bordeaux, 33075
Institut Bergonie
Bordeaux, 33076
Centre Francois Baclesse
Caen, 14076
Hopital Henri Mondor
Créteil, 94010
Centre Leon Berard
Lyon, 69008
Institut Paoli Calmettes
Marseille, 13273
Centre Alexis Vautrin
Nancy, 54511
Centre Rene Gauducheau
Nantes, 44800
Chu de Nimes
Nîmes, 30029
Institut Curie
Paris, 75005
Diaconesses - Croix St Simon
Paris, 75012
Pitie Salpetriere
Paris, 75013
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Institut Cancerologie de La Loire
Saint-Priest-en-Jarez, 42270
Hopitaux Universitaires
Strasbourg, 67091
Institut Claudius Regaud
Toulouse, 31052
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Intensified Methotrexate, Vinblastine, Doxorubicin and Cisplatin +/-Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma in Patients Without Harvey Nor Kirsten Rat Sarcoma Viral Oncogene Homolog Mutations. Phase II Study
OBJECTIVES OF THE TRIAL
Primary objective
Evaluation of efficacy in terms of progression-free survival at 9 months of the combination of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations.
Secondary objectives
- To assess toxicity
- To assess response rate
- To assess overall survival
- To assess time to progression
- To study the correlation between response rate, time to progression, overall survival and biological parameters
- Being tested
- Chemotherapy, Panitumumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called Intensified-Methotrexate Vinblastine Doxorubicin Cisplatin, I-MVAC
METHOTREXATE: 30 mg/m² on day 1 VINBLASTINE: 3 mg/m² on day 2 DOXORUBICIN: 30 mg/m² on day 2 CISPLATIN: 70 mg/m² on day 2
PanitumumabDrug
PANITUMUMAB: 6 mg/kg on day 2
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Active comparator | Intensified- Methotrexate Vinblastin Doxorubicin Cisplatin Receives: Drug: Chemotherapy |
| Arm B: chemotherapy + panitumumab | Experimental | Intensified- Methotrexate Vinblastin Doxorubicin Cisplatin +/- panitumumab Receives: Drug: Chemotherapy; Drug: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Progression-Free Survival at 9 months post-treatment
Measured: 9 months
Secondary outcomes (4)
Toxicities assessment
toxicity (CTC AE v4.0) after end of treatment
Measured: 24 months
Evaluation of response
Recist 1.1
Measured: 24 months
Evaluation of overall survival
Measured: 24 months
Evaluation of time to progression
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startJun 2010
- Primary completionSep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infiltrating Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818725
- Sponsor's protocol ID
- GETUG-AFU 19/0903
- Other IDs
- 2009-011882-10, 2009
- Acronym
- GETUG-AFU19
- Status last verified
- Mar 2021
- First submitted
- 29 Nov 2011
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensified Methotrexate, Vinblastine, Doxorubicin and Cisplatin +/-Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma in Patients Without Harvey Nor Kirsten Rat Sarcoma Viral Oncogene Homolog Mutations. Phase II Study
- ClinicalTrials.gov ID
- NCT02818725
- Acronym / sponsor ID
- GETUG-AFU19 / GETUG-AFU 19/0903
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Jun 2010 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES OF THE TRIAL
Primary objective
Evaluation of efficacy in terms of progression-free survival at 9 months of the combination of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations.
Secondary objectives
- To assess toxicity
- To assess response rate
- To assess overall survival
- To assess time to progression
- To study the correlation between response rate, time to progression, overall survival and biological parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Active comparator | Drug: ChemotherapyIntensified- Methotrexate Vinblastin Doxorubicin Cisplatin |
| Arm B: chemotherapy + panitumumab | Experimental | Drug: Chemotherapy, Drug: PanitumumabIntensified- Methotrexate Vinblastin Doxorubicin Cisplatin +/- panitumumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Primary tumour of the bladder or upper urinary tract
- Histologically confirmed infiltrating urothelial carcinoma (epidermoid and/or glandular forms are accepted)
- Patients without Harvey and Kirsten-rat sarcoma viral oncogene homolog mutations
- Advanced disease defined by a locally advanced stage (T4 and/or N+) ineligible for surgical resection, or a metastatic stage (M1)
- Patients with at least 1 evaluable lesion as per Response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
Key exclusion criteria (14 listed)
- Pure adenocarcinoma or pure epidermoid carcinoma or mixed or pure small-cell neuroendocrine carcinoma
- Previous treatment with one of the following molecules: methotrexate, vinblastine, doxorubicin or Epidermal Growth Factor inhibitor
- History of interstitial pneumonitis or pulmonary fibrosis
- History of cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled serious cardiac arrhythmia) in the year prior to randomisation (≤1 year)
- Ventricular ejection fraction <50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyAlso: Intensified-Methotrexate Vinblastine Doxorubicin Cisplatin, I-MVACMETHOTREXATE: 30 mg/m² on day 1 VINBLASTINE: 3 mg/m² on day 2 DOXORUBICIN: 30 mg/m² on day 2 CISPLATIN: 70 mg/m² on day 2 | Drug | Arm B: chemotherapy + panitumumab, Chemotherapy |
| PanitumumabPANITUMUMAB: 6 mg/kg on day 2 | Drug | Arm B: chemotherapy + panitumumab |
Primary outcome
Time to progression
Time frame: 9 months
Progression-Free Survival at 9 months post-treatment
4 secondary outcomes
Toxicities assessment
Time frame: 24 months
Evaluation of response
Time frame: 24 months
Evaluation of overall survival
Time frame: 24 months
Evaluation of time to progression
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chemotherapy and Panitumumab in people with Infiltrating Urothelial Carcinoma and KRAS Gene Mutation, run by UNICANCER at 17 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 13 inclusion and 14 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 17 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 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?
Time to progression (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.