A Phase 2 interventional study of Methotrexate and Vinblastine in Bladder Cancer, sponsored by Hellenic Oncology Research Group. Terminated at 7 sites in Greece. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-10-08.
Sponsored by Hellenic Oncology Research Group · Phase 2, Interventional, and Treatment
This phase II trial will study the effectiveness and toxicity of sequential high dose MVAC followed by gemcitabine and cisplatin, as first line treatment in patients with locally advanced or metastatic bladder cancer.
High dose MVAC and Cisplatin/Gemcitabine combination regimens have shown comparable efficacy in the first line treatment of advanced or metastatic bladder cancer, whereas the latter regimen has better tolerability. The efficacy and tolerability of the sequential administration of these two regimens is not known.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 41 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Hellenic Oncology Research Group is the lead sponsor of 57 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Measurable disease is defined as at least 1 unidimensional measurable lesion
≥20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease.
Exclusion Criteria:
MVAC -\> GEM+CDDP
Drug: Methotrexate · Drug: Vinblastine · Drug: Doxorubicin · Drug: Cisplatin · Drug: Gemcitabine
Methotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses
Vinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses
Doxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses
Cisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses
Also known as: CDDP
Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses
Also known as: CDDP
Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses
Also known as: Gemzar
Overall response rate
Time frame: Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)
Time to tumor progression
Time frame: 1-year
Overall survival
Time frame: 1-year
Toxicity profile
Time frame: Toxicity assessment on each chemotherapy cycle
This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Hellenic Oncology Research Group