Dose Dense MVAC for Muscle Invasive Bladder Cancer

Completed · Phase 2

Conditions studied: Muscle Invasive Bladder Cancer, High Risk Urothelial Carcinoma of the Upper Urinary Tracts

In brief

Standard treatment for early stage bladder cancer is chemotherapy with methotrexate (M), vinblastine (V), adriamycin (A), and cisplatin (C) followed by surgical removal of any remaining cancer and the bladder with the intent of cure. The M V chemotherapy is usually given every 14 days with the AC given along each 28 days. This study looks at giving the same drugs at the same doses closer together, all drugs every 14 days, with the support of growth factor medication to promote growth of the white blood cells and platelets and allow chemotherapy to be finished sooner and surgery to be done sooner.

Key facts

Study ID

NCT01031420

Run by

Fox Chase Cancer Center

People needed

54

Starts

2009-12-07

Expected to finish

2013-08-07

Last updated by the study team

2019-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• histologically confirmed urothelial carcinoma of bladder, ureter, or renal pelvis. T2-T4 and muscle invasion must be established by TURBT. Upper tract must be high grade. N0-N1 are eligible.
• candidate for radical cystectomy, nephroureterectomy, or segmental ureterectomy with goal of cure.
• >/= 18 years old
• ECOG performance status 0-1.
• Adequate marrow and organ function.
• May enter on therapeutic anticoagulation if it can be safely held during perioperative period.
• No women of childbearing potential, pregnant or breastfeeding.
• LVEF >/= 50 %
• Patients with history of other non-urothelial malignancies may enroll if: 1)no evidence of distant disease w/in last year. 2)No anticancer treatment for >/= 1 year other than adjuvant treatment or treatment for secondary prevention. 3) Less than 360 mg/m2 lifetime dose of adriamycin.
• ability to understand and willingness to sign written informed consent and HIPAA.

You may not qualify if…

• Intravesicular therapy w/in 4 weeks of study entry or those who have not recovered from adverse effects of such agents administered more than 4 weeks earlier.
• Patients may not be receiving any investigational agents within 4 weeks of study entry.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Methotrexate, Vinblastine, Adriamycin or Cisplatin or other agents used in the study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study due to the potential for teratogenic or abortifacient effects of cytotoxic chemotherapy.
• Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with cytotoxic chemotherapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
• . Patients who have undergone prior pelvic radiation are excluded due to risk of life threatening myelosuppression.
• Patients who have received any previous systemic chemotherapy or radiation therapy for urothelial carcinoma or cytotoxic chemotherapy for another malignancy within 1 year of study entry are ineligible.

Where it is running

• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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