Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma
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ClinicalTrials.gov Identifier: NCT00808639 |
Recruitment Status :
Completed
First Posted : December 16, 2008
Results First Posted : May 15, 2014
Last Update Posted : October 24, 2016
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Condition or disease | Intervention/treatment | Phase |
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Bladder Cancer Muscle-invasive Bladder Cancer | Drug: Methotrexate Drug: Doxorubicin Drug: vinblastine Drug: cisplatin Drug: Pegfilgrastim | Phase 2 |
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial of Neoadjuvant Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | September 2016 |

Arm | Intervention/treatment |
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Experimental: Dose Dense MVAC
Chemo therapy with methotrexate, vinblastine, Adriamycin, Cisplatin
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Drug: Methotrexate
intravenously 30mg/m2 over 30 minutes Drug: Doxorubicin intravenously 30mg/ms over 15 minutes Drug: vinblastine intravenously 3mg/m2 over 30 minutes Drug: cisplatin intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion Drug: Pegfilgrastim Given subcutaneously 24 hours after last chemotherapy dose |
- Number of Patients Achieving Pathologic Response [ Time Frame: After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks) ]Pathological response is defined as down-staging to </=pT1, N0 after chemotherapy with pegfilgrastim support.
- Number of Patients Experiencing Febrile Neutropenia [ Time Frame: After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks) ]Febrile neutropenia defined per CTCAEv3 as Grade 3 or higher and treatment attribution possibly, probably or definitely-related.
- Number of Patients Experiencing Surgery-related Toxicity [ Time Frame: Surgery + 30 days ]Surgery-related toxicity defined per CTCAEv3 as Grade 2 or higher and treatment attribution possibly, probably or definitely-related.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologic proof of urothelial cancer. Patients with all histologic subtypes are eligible as long as transitional cell carcinoma is predominant, with the exception of more than a few clusters of small cell carcinoma, which is treated with different chemotherapy and thus are ineligible
- Patients with primary tumors arising in the bladder or urethra are eligible if they have clinical T2-T4a disease
- Patients with primary tumors arising in the ureter or renal pelvis are eligible if they have either grade 3 tumors, or radiographic abnormality large enough to be recognized as an abnormal mass by CT/imaging
- Evaluation by a urologist and be deemed to be acceptable surgical candidates within 3 months of registration
- Adequate physiologic reserves as outlined in the protocol
- Clinical or pathologic N1 lymph node involvement (involvement of a single lymph node < 2cm in greatest dimension) are eligible. Patients with N2-3 or M1 disease are ineligible
- Determination of LV function with an EF > 50%
- Women of child-bearing potential must have a negative pregnancy test
- Patients of child-bearing or father-bearing potential must agree to use an acceptable form of birth control while on the study
- Patients with prior malignancy are eligible provided that the expected outcome from the prior cancer is such that this will not interfere in the delivery of this therapy, or the assessment of response in the cystectomy specimen
- 18 years of age or older
Exclusion Criteria:
- Current, recent (within 3 weeks), or planned participation with other experimental anti-cancer medications as part of clinical trials
- Prior treatment with doxorubicin
- Prior systemic cytoreductive chemotherapy for bladder cancer
- Blood pressure of > 160/100 mmHg. Patients whose blood pressure can be controlled with oral medication are eligible
- NYHA Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Known history of central nervous system or brain metastases
- Major surgical procedure, significant traumatic injury within 21 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
- Lactating women
- Patients who are not candidates for surgery, or unwilling to undergo surgery
- Patients with significant fluid collection
- Known hypersensitivity to any component of cisplatin, methotrexate, vinblastine, doxorubicin or pegfilgrastim

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808639
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Lahey Clinic | |
Burlington, Massachusetts, United States, 01805 | |
United States, Pennsylvania | |
University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 |
Principal Investigator: | Toni Choueiri, MD | Dana-Farber Cancer Institute |
Responsible Party: | Toni Choueiri, MD, Assistant Professor of Medicine, Harvard Medical School, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00808639 |
Other Study ID Numbers: |
08-208 |
First Posted: | December 16, 2008 Key Record Dates |
Results First Posted: | May 15, 2014 |
Last Update Posted: | October 24, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
pegfilgrastim MVAC |
Urinary Bladder Neoplasms Carcinoma, Transitional Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases Cisplatin Doxorubicin Methotrexate Vinblastine |
Antineoplastic Agents Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Dermatologic Agents Folic Acid Antagonists Immunosuppressive Agents |