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COMPLETED Phase 2

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

NCT00808639 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Doxorubicin
  • DRUG Methotrexate
  • DRUG cisplatin
  • DRUG Pegfilgrastim
  • DRUG vinblastine

Study Locations (4)

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston
  • Dana-Farber Cancer Institute — Boston
  • Lahey Clinic — Burlington

Pennsylvania

  • University of Pittsburgh Cancer Institute — Pittsburgh

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2008-12
Est. Completion 2016-09
Phase Phase 2

Sponsor

Dana-Farber Cancer Institute

819 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00808639

The ClinicalTrials.gov registry entry for NCT00808639 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 819 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 5 interventions — of which Doxorubicin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00808639 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00808639 about?

NCT00808639 is a clinical study titled "Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma". 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.

What is the current status of trial NCT00808639?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2008-12. Estimated completion is 2016-09.

What conditions does trial NCT00808639 study?

This clinical trial studies the following conditions: Bladder Cancer, Muscle-invasive Bladder Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00808639?

The interventions under investigation include: Doxorubicin (DRUG), Methotrexate (DRUG), cisplatin (DRUG), Pegfilgrastim (DRUG), vinblastine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00808639?

This trial is sponsored by Dana-Farber Cancer Institute, which has 819 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00808639 being conducted?

This trial has 4 study locations across Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial