Methotrexate, Vinblastine, Doxorubicin and Cisplatin (MVAC) Followed by Gemcitabine Plus Cisplatin (GEM+CDDP) in Locally Advanced or Metastatic Bladder Cancer

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00635726
• Other study ID #: CT/07.16
• Status: Terminated
• Phase: Phase 2
• First received: March 11, 2008
• Last updated: October 7, 2015
• Start date: February 2008
• Est. completion date: February 2013

Study information

• Verified date: October 2015
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Methotrexate
Methotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses
• Vinblastine
Vinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses
• Doxorubicin
Doxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses
• Cisplatin
Cisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses
• Cisplatin
Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses
• Gemcitabine
Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dept. of Medical Oncology	Alexandroupolis
Greece	401 Military Hospital, Medical Oncology Unit	Athens
Greece	Air Forces Military Hospital, Dept. of Medical Oncology	Athens
Greece	IASO General Hospital of Athens, 1st Dept. of Medical Oncology	Athens
Greece	Laikon General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine	Athens
Greece	Metaxa's Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology	Piraeus
Greece	Theagenion Anticancer Hospital of Thessaloniki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)	No
Secondary	Time to tumor progression		1-year	No
Secondary	Overall survival		1-year	No
Secondary	Toxicity profile		Toxicity assessment on each chemotherapy cycle	Yes