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GETUG-AFU19: I-MVAC +/- Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma Without H-Ras Nor K-Ras Mutations

Sponsor
UNICANCER (Other)
Overall Status
Completed
CT.gov ID
NCT02818725
Collaborator
(none)
133
Enrollment
17
Locations
2
Arms
87
Actual Duration (Months)
7.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
133 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Chemotherapy

Intensified- Methotrexate Vinblastin Doxorubicin Cisplatin

Drug: Chemotherapy
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
Other Names:
  • Intensified-Methotrexate Vinblastine Doxorubicin Cisplatin
  • I-MVAC

    		•
    Experimental: Arm B: chemotherapy + panitumumab

    Intensified- Methotrexate Vinblastin Doxorubicin Cisplatin +/- panitumumab

    Drug: Chemotherapy
    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
    Other Names:
  • Intensified-Methotrexate Vinblastine Doxorubicin Cisplatin
  • I-MVAC

    • Drug: Panitumumab
    PANITUMUMAB: 6 mg/kg on day 2

    Outcome Measures

    Primary Outcome Measures

    1. Time to progression [9 months]

      Progression-Free Survival at 9 months post-treatment

    Secondary Outcome Measures

    1. Toxicities assessment [24 months]

      toxicity (CTC AE v4.0) after end of treatment

    2. Evaluation of response [24 months]

      Recist 1.1

    3. Evaluation of overall survival [24 months]

    4. Evaluation of time to progression [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Primary tumour of the bladder or upper urinary tract

    2. Histologically confirmed infiltrating urothelial carcinoma (epidermoid and/or glandular forms are accepted)

    3. Patients without Harvey and Kirsten-rat sarcoma viral oncogene homolog mutations

    4. Advanced disease defined by a locally advanced stage (T4 and/or N+) ineligible for surgical resection, or a metastatic stage (M1)

    5. Patients with at least 1 evaluable lesion as per Response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)

    6. 18 ≤ age ≤ 75 years

    7. General condition 0 or 1 as per the WHO scale

    8. 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)

    9. Haematological function: Haemoglobin >11 g/dl, neutrophils ≥1500/mm³, platelets ≥100,000/mm³

    10. Liver function: Grade* 0 Aspartate aminotransferase and Alanine aminotransferase (< grade* 3 for liver metastases), grade* 0 alkaline phosphatases, normal bilirubin

    11. Renal function: calculated (or measured) creatinine clearance >60 ml/min

    12. Patients covered by a social security scheme

    13. Patient having read the information sheet and signed the informed consent form.

    Exclusion Criteria:

    1. Pure adenocarcinoma or pure epidermoid carcinoma or mixed or pure small-cell neuroendocrine carcinoma

    2. Previous treatment with one of the following molecules: methotrexate, vinblastine, doxorubicin or Epidermal Growth Factor inhibitor

    3. History of interstitial pneumonitis or pulmonary fibrosis

    4. 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)

    5. Ventricular ejection fraction <50%

    6. Blood calcium and/or magnesium ≥ grade* 1

    7. 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,

    8. Treatment with radiotherapy for analgesic purposes (unless treatment was discontinued at least 15 days prior to inclusion in the trial)

    9. Potential allergy to panitumumab

    10. 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

    11. Pregnant women, or female subjects liable to become pregnant or currently breast-feeding,

    12. Patient already included in another therapeutic trial on an investigational medicinal product,

    13. Persons deprived of their freedom or under judicial protection (including guardianship),

    14. Unable to receive medical follow-up during the trial owing to geographical, social or psychological reasons.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopital Saint Andre Bordeaux France 33075
    2 Institut Bergonie Bordeaux France 33076
    3 Centre Francois Baclesse Caen France 14076
    4 Hopital Henri Mondor Creteil France 94010
    5 Centre Leon Berard Lyon France 69008
    6 Institut Paoli Calmettes Marseille France 13273
    7 Centre Alexis Vautrin Nancy France 54511
    8 Centre Rene Gauducheau Nantes France 44800
    9 Chu de Nimes Nimes France 30029
    10 Institut Curie Paris France 75005
    11 Diaconesses - Croix St Simon Paris France 75012
    12 Pitie Salpetriere Paris France 75013
    13 Centre Hospitalier Lyon Sud Pierre Benite France 69495
    14 Institut Cancerologie de La Loire St Priest En Jarez France 42270
    15 Hopitaux Universitaires Strasbourg France 67091
    16 Institut Claudius Regaud Toulouse France 31052
    17 Institut Gustave Roussy Villejuif France 94805

    Sponsors and Collaborators

    • UNICANCER

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UNICANCER
    ClinicalTrials.gov Identifier:
    NCT02818725
    Other Study ID Numbers:
    • GETUG-AFU 19/0903
    • 2009-011882-10
    First Posted:
    Jun 30, 2016
    Last Update Posted:
    Mar 9, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Transitional Cell
    Cisplatin
    Doxorubicin
    Methotrexate
    Panitumumab
    Vinblastine

    Study Results

    No Results Posted as of Mar 9, 2021