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

Phase 2

Terminated

• Conditions: Bladder Cancer
• Interventions: Drug: Methotrexate; Drug: Vinblastine; Drug: Doxorubicin; Drug: Cisplatin; Drug: Gemcitabine

• Registration Number: NCT00635726
• Lead Sponsor: Hellenic Oncology Research Group

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-13
• Study First Posted: 2008-03-14
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Doxorubicin	MVAC -\> GEM+CDDP
1	Cisplatin	MVAC -\> GEM+CDDP
1	Gemcitabine	MVAC -\> GEM+CDDP
1	Methotrexate	MVAC -\> GEM+CDDP
1	Vinblastine	MVAC -\> GEM+CDDP

Primary Outcome Measures

Name	Time	Method
Overall response rate	Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)

Secondary Outcome Measures

Name	Time	Method
Time to tumor progression	1-year
Overall survival	1-year
Toxicity profile	Toxicity assessment on each chemotherapy cycle

Trial Locations

Locations (7)

IASO General Hospital of Athens, 1st Dept. of Medical Oncology; 🇬🇷 Athens, Greece

University General Hospital of Alexandroupolis, Dept. of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

Metaxa's Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology; 🇬🇷 Piraeus, Greece

401 Military Hospital, Medical Oncology Unit; 🇬🇷 Athens, Greece

Air Forces Military Hospital, Dept. of Medical Oncology; 🇬🇷 Athens, Greece

Laikon General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine; 🇬🇷 Athens, Greece

Theagenion Anticancer Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece