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

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ClinicalTrials.gov Identifier: NCT02818725
Recruitment Status : Unknown
Verified June 2016 by UNICANCER.
Recruitment status was:  Active, not recruiting
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
UNICANCER

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
Infiltrating Urothelial Carcinoma KRAS Gene Mutation Drug: Chemotherapy Drug: panitumumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 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
Study Start Date : June 2010
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017


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




Primary Outcome Measures :
  1. Time to progression [ Time Frame: 9 months ]
    Progression-Free Survival at 9 months post-treatment


Secondary Outcome Measures :
  1. Toxicities assessment [ Time Frame: 24 months ]
    toxicity (CTC AE v4.0) after end of treatment

  2. Evaluation of response [ Time Frame: 24 months ]
    Recist 1.1

  3. Evaluation of overall survival [ Time Frame: 24 months ]
  4. Evaluation of time to progression [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 RECIST criteria (version 1.1)
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818725


Locations
France
Hopital Saint Andre
Bordeaux, France, 33075
Institut Bergonie
Bordeaux, France, 33076
Centre Francois Baclesse
Caen, France, 14076
Hopital Henri Mondor
Creteil, France, 94010
Centre Leon Berard
Lyon, France, 69008
Institut Paoli Calmettes
Marseille, France, 13273
Centre Alexis Vautrin
Nancy, France, 54511
Centre Rene Gauducheau
Nantes, France, 44800
Chu de Nimes
Nimes, France, 30029
Institut Curie
Paris, France, 75005
Diaconesses - Croix St Simon
Paris, France, 75012
Pitie Salpetriere
Paris, France, 75013
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Institut Cancerologie de La Loire
St Priest En Jarez, France, 42270
Hopitaux Universitaires
Strasbourg, France, 67091
Institut Claudius Regaud
Toulouse, France, 31052
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
UNICANCER

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT02818725     History of Changes
Other Study ID Numbers: GETUG-AFU 19/0903
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liposomal doxorubicin
Cisplatin
Doxorubicin
Methotrexate
Vinblastine
Antibodies, Monoclonal
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Phytogenic