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Clinical Trials/EUCTR2009-011882-10-FR
EUCTR2009-011882-10-FRActive, not recruitingNot Applicable

Intensified methotrexate, vinblastine, doxorubicin and cisplatin (I-MVAC) with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without H-Ras nor K-Ras mutations. Randomised phase II study.

FNCLCC (Fédération Nationale des Centres de Lutte Contre le Cancer)0 sitesStarted: January 4, 2010Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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 H-Ras nor K-Ras 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 ASAT and ALAT (< 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.
  • •* CTC AE v4.0
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

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 EGF-R 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.
  • •* CTC AE v4.0

Investigators

Sponsor
FNCLCC (Fédération Nationale des Centres de Lutte Contre le Cancer)

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