NCT02818725

Brief 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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_3

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

6.3 years

First QC Date

November 29, 2011

Last Update Submit

March 4, 2021

Conditions

Infiltrating Urothelial CarcinomaKRAS Gene Mutation

Outcome Measures

Primary Outcomes (1)

  • Time to progression

    Progression-Free Survival at 9 months post-treatment

    9 months

Secondary Outcomes (4)

  • Toxicities assessment

    24 months

  • Evaluation of response

    24 months

  • Evaluation of overall survival

    24 months

  • Evaluation of time to progression

    24 months

Study Arms (2)

Chemotherapy

ACTIVE COMPARATOR

Intensified- Methotrexate Vinblastin Doxorubicin Cisplatin

Drug: Chemotherapy

Arm B: chemotherapy + panitumumab

EXPERIMENTAL

Intensified- Methotrexate Vinblastin Doxorubicin Cisplatin +/- panitumumab

Drug: ChemotherapyDrug: Panitumumab

Interventions

ChemotherapyDRUG

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

Also known as: Intensified-Methotrexate Vinblastine Doxorubicin Cisplatin, I-MVAC
Arm B: chemotherapy + panitumumabChemotherapy
PanitumumabDRUG

PANITUMUMAB: 6 mg/kg on day 2

Arm B: chemotherapy + panitumumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • ≤ age ≤ 75 years
  • 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.

You may not qualify if:

  • 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
  • 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,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Hopital Saint Andre

Bordeaux, 33075, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Francois Baclesse

Caen, 14076, France

Location

Hopital Henri Mondor

Créteil, 94010, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Centre Alexis Vautrin

Nancy, 54511, France

Location

Centre Rene Gauducheau

Nantes, 44800, France

Location

Chu de Nimes

Nîmes, 30029, France

Location

Institut Curie

Paris, 75005, France

Location

Diaconesses - Croix St Simon

Paris, 75012, France

Location

Pitie Salpetriere

Paris, 75013, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Institut Cancerologie de La Loire

Saint-Priest-en-Jarez, 42270, France

Location

Hopitaux Universitaires

Strasbourg, 67091, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Interventions

Drug TherapyPanitumumab

Intervention Hierarchy (Ancestors)

TherapeuticsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2011

First Posted

June 30, 2016

Study Start

June 1, 2010

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Locations

FR(17)