Prospective, randomized phase III study of two intensified treatment groups [Methotrexate/Vinblastine/Adriamycin/Cisplatin (MVAC) vs. Gemcitabine/Cisplatin] in patients with inoperable or recurrent urothelial cancer

Prospective, randomized phase III study to compare survival between two intensified treatment groups (Methotrexate/Vinblastine/Adriamycin/Cisplatin (MVAC) vs. Gemcitabine/Cisplatin) in patients with inoperable or recurrent urothelial cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000845033

Enrollment

206

Registered

2010-10-07

Start date

2003-11-11

Completion date

2008-01-23

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a randomized phase III study of two intensified treatment groups (Methotrexate, Vinblastine, Adriamycin, Cisplatin (MVAC) vs. Gemcitabine/Cisplatin) in patients with inoperable or recurrent urothelial cancer. The primary outcome is to compare the survival between the two groups. The secondary outcomes are to compare the Time to Progression, Response Rate and Toxicity between the two groups.

Interventions

Gemcitabine 2500mg/m^2 intravenously infused (iv) over 30 min (day 1) immediately followed by Cisplatin 70mg/m^2 iv over 60 min (day 1) Gemcitabine is administered before Cisplatin. Treatment will be repeated every 2 weeks for a minimum of 6 cycles unless disease progression or intolerability. Maximum number of cycles 12

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically confirmed inoperable or recurrent transitional cell advanced urothelial cancer 2. Age of >18 years 3. Life expectancy > 3 months 4. No prior chemotherapy for advanced disease is allowed 5. Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1 6. Creatinine clearance > 50 ml/min (Cockroft Formula) 7. Absolute Neutrophil Count (ANC)>= 1,500 /Microlitre (microL), platelets>= 100,000 /microL, bilirubin and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <2N 8. Absence of cardiac failure. Patients previously treated with adriamycin are excluded from the study. Patients with cardiac disease should demonstrate a baseline left ventricular ejection fraction (LVEF) >50% 9. Signed Informed Consent

Exclusion criteria

1.Other histology types of urothelial cancer. Mixed histology types mainly of transitional cell cancer are allowed. 2.History of other neoplasm within the 5 last years except for radically excised basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix. 3.Prior adjuvant or neo-adjuvant chemotherapy containing adriamycin. Patients who received adjuvant or neo-adjuvant chemotherapy with Gemcitabine/Cisplatin or Gemcitabine/Carboplatin within the last 12 months are excluded. 4.Any active infection or other uncontrolled underlying condition (infection, cardiac arrythmia, diabetes mellitus) 5.Women of reproductive age should obtain a negative pregnancy test. All sexually active patients should take efficient contraceptive measures.

Outcome results