Neoadjuvant Chemotherapy With Methotrexate, Vinblastine, Adriamycin and Cisplatin (M-VAC) Plus Avastin in Patients With Urothelial Cancer
The goal of this clinical research study is to learn how well bladder cancer responds to a combination treatment with Avastin and M-VAC (methotrexate, doxorubicin, vinblastine, and cisplatin) before surgery to remove the tumor.
To estimate the response of patients with locally advanced urothelial cancer treated with neoadjuvant chemotherapy with a combination of Dose Dense Methotrexate, Vinblastine, Adriamycin, and Cisplatin (DD-M-VAC) plus Avastin followed by radical surgery with curative intent. In this context, response will be defined as the absence of residual muscle invasive cancer in the resected specimen (<= pT1, N0.)
To estimate the 4-year disease-free survival of patients with locally advanced urothelial cancer treated with neoadjuvant chemotherapy with DD-M-VAC plus Avastin followed by radical surgery with curative intent.
Document perioperative morbidity and mortality in this cohort, with reference to well-established historical standards.
Determine the effects of VEGF inhibition on angiogenesis and angiogenesis-related gene expression utilizing fluorescent tissue staining techniques that we have developed in the laboratory (such as two-color TUNEL, phospho-receptor, and microvessel density).
Interrogate downstream receptor signaling pathways to provide insight into the development of chemotherapy resistance, and hence hypothesis for its prevention.
|Bladder Cancer||Drug: Avastin Drug: Cisplatin Drug: Doxorubicin Drug: Methotrexate Drug: Vinblastine Sulfate||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical Trial of Neoadjuvant Chemotherapy With M-VAC Plus Avastin in Patients With Locally Advanced Urothelial Cancer|
- Percentage of Participants With Response Defined as the Absence of Residual Muscle Invasive Cancer in Resected Specimen [ Time Frame: Following 20 weeks of chemotherapy ]Number of participants out of total with a response defined as "downstaging" to <= pT1N0 in the resected specimen. A binary variable was defined for downstaging (pathologic stage below initial clinical stage and below pT1N1N0M0); staging using American Joint Committee on Cancer (AJCC) TNM system of "TNM"; T describes size tumor & cancer spread into nearby tissue; N describes spread to nearby lymph nodes; & M describes metastasis (spread to other parts of body). Numbers after T (such as T1, T2, T3, and T4) describe tumor size and/or amount of spread into nearby structures, higher the T number, the larger the tumor and/or more it has grown into nearby tissues. Responses of lesser magnitude scored as treatment failure. Response Evaluation Criteria In Solid Tumors (RECIST) criteria do not apply for this cohort of neoadjuvant participants since this study does not require measurable disease by traditional assessment.
- 5-year Overall Survival (OS) [ Time Frame: 5 years ]The overall survival rate stated as a five-year survival rate, which is the percentage of participants in study who are alive five years after the start of treatment.
|Study Start Date:||June 2007|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Neoadjuvant Chemotherapy with M-VAC + Avastin
Avastin 10 mg/kg by vein over 90 minutes. Cisplatin 70 mg/m^2 by vein over 4 hours. Doxorubicin 30 mg/m^2 by vein over 15 minutes. Methotrexate 30 mg/m^2 by vein over 30 minutes. Vinblastine Sulfate 3 mg/m^2 by vein over 30 minutes.
10 mg/kg by vein over 90 minutes
Other Names:Drug: Cisplatin
70 mg/m^2 by vein over 4 hours
Other Names:Drug: Doxorubicin
30 mg/m^2 by vein over 15 minutes
Other Names:Drug: Methotrexate
30 mg/m^2 by vein over 30 minutesDrug: Vinblastine Sulfate
3 mg/m^2 by vein over 30 minutes
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506155
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Arlene Siefker-Radtke, MD||M.D. Anderson Cancer Center|