Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Natriuretic Agents

Anti-Infective Agents

Micronutrients

Hematinics

Vitamins

Doxorubicin

Liposomal doxorubicin

Methotrexate

Cisplatin

Mannitol

Vinblastine

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antimetabolites

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Tubulin Modulators

Antimitotic Agents

Folinic Acid

Folate

Vitamin B9

Chemo therapy with methotrexate, vinblastine, Adriamycin, Cisplatin

vinblastine

intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion

cisplatin

Given subcutaneously 24 hours after last chemotherapy dose

Pegfilgrastim

Toni Choueiri, MD

The purpose of this research study is to test the effectiveness of neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) in combination with pegfilgrastim followed by radical surgery in patients with muscle-invasive urothelial carcinoma.

* Participants will be given a study infusion schedule for each treatment cycle. Each treatment cycle lasts three weeks. The infusion of methotrexate will take place on the first day of each cycle. Infusions of vinblastine, doxorubicin and cisplatin will take place on the second day and an injection of pegfilgrastim will be given on the third day.
* During all treatment cycles participants will have a physical exam and will be asked questions about their general health and any problems they might be having and any medications they may be taking.
* Following completion of study treatment, but before surgery, participants will have an assessment of their tumor by CT scan of the chest and and MRI of the abdomen and pelvis.
* Following the participants surgery, we would like to keep track of their medical condition indefinitely, or until this study is officially completed. We would like to do this by calling the participants on the telephone once a year to see how they are doing.

Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma

A Phase II Trial of Neoadjuvant Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma

Pathological response is defined as down-staging to \</=pT1, N0 after chemotherapy with pegfilgrastim support.

Febrile neutropenia defined per CTCAEv3 as Grade 3 or higher and treatment attribution possibly, probably or definitely-related.

Surgery-related toxicity defined per CTCAEv3 as Grade 2 or higher and treatment attribution possibly, probably or definitely-related.

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Amgen

Dana-Farber Cancer Institute

Assistant Professor of Medicine, Harvard Medical School

Toxicities are reported by toxicity type and maximum grade (consolidates the reports of a given type of toxicity for a patient over time) for attributions possibly, probably and definitely related to treatment only. Patients with reports of multiple toxicities of different types are reported multiple times under the relevant toxicity categories.

Methotrexate: intravenously 30mg/m2 over 30 minutes

Doxorubicin: intravenously 30mg/ms over 15 minutes

vinblastine: intravenously 3mg/m2 over 30 minutes

cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion

Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose

Dose Dense MVAC

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

This study used a Simon's optimal two-stage design. Of 39 eligible patients, if 18 achieved PaR, the treatment would be declared effective. A two-sided 80% CI was estimated considering the two-stage design based on Atkinson and Brown methods.

Analysis population consists of all enrolled patients.

Number of Patients Achieving Pathologic Response

Number of Patients Experiencing Febrile Neutropenia

Number of patients who underwent cystectomy.

Number of Patients Experiencing Surgery-related Toxicity

Dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma	NCT00808639	Bladder Cancer Muscle-invasive...	Methotrexate Doxorubicin vinblastine cisplatin Pegfilgrastim	18 Years -	Dana-Farber Cancer Institute
Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma	NCT00808639	Bladder Cancer Muscle-invasive...	Methotrexate Doxorubicin vinblastine cisplatin Pegfilgrastim	18 Years -	Dana-Farber Cancer Institute
Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma	NCT00808639	Bladder Cancer Muscle-invasive...	Methotrexate Doxorubicin vinblastine cisplatin Pegfilgrastim	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for mvac

Every month we try and update this database with for mvac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mvac

Every month we try and update this database with for mvac cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mvac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.