Clinical trial NCT00635726: Methotrexate, Vinblastine, Doxorubicin and Cisplatin (MVAC) Followed by Gemcitabine Plus Cisplatin (GEM+CDDP) in Locally Advanced or Metastatic Bladder Cancer
Official title: Sequential High Dose MVAC (Methotrexate, Vinblastine, Doxorubicin and Cisplatin), Followed by Gemcitabine Plus Cisplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: Bladder Cancer
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2008-03-14
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed transitional cell carcinoma of the urinary bladder.
* Metastatic or locally advanced disease.
* No prior chemotherapy.
* Performance status (World Health Organization) 0-2.
* Measurable or evaluable disease.
* 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.
* Adequate liver (bilirubin ≤ 1.5 Upper Normal Limit, serum glutamate-pyruvate aminotransferase/serum glutamic pyruvic transaminase ≤ 2 Upper Normal Limit, ALP ≤ 2.5 Upper Normal Limit), renal (creatinine ≤ 1.5 Upper Normal Limit) and bone marrow (absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3) function.
* Life expectancy \> 3 months.
* Patients must be able to understand the nature of this study and give written informed consent.

Exclusion Criteria:

* History of serious cardiac disease (unstable angina, severe congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias).
* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
* Active infection.
* Uncontrolled inflammation.
* Pregnant or lactating women.
* Psychiatric illness or social situation that would preclude study compliance.

Primary outcomes:
measure: Overall response rate
timeFrame: Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)
Secondary outcomes:
measure: Time to tumor progression
timeFrame: 1-year
measure: Overall survival
timeFrame: 1-year
measure: Toxicity profile
timeFrame: Toxicity assessment on each chemotherapy cycle
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dept. of Medical Oncology
city: Athens
country: Greece
facility: 401 Military Hospital, Medical Oncology Unit
city: Athens
country: Greece
facility: Air Forces Military Hospital, Dept. of Medical Oncology
city: Athens
country: Greece
facility: IASO General Hospital of Athens, 1st Dept. of Medical Oncology
city: Athens
country: Greece
facility: Laikon General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine
city: Piraeus
country: Greece
facility: Metaxa's Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology
city: Thessaloniki
country: Greece
facility: Theagenion Anticancer Hospital of Thessaloniki
Study officials:
affiliation: University Hospital of Crete, Dept. of Medical Oncology
name: Nikos Androulakis, MD
role: PRINCIPAL_INVESTIGATOR
References: