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NCT00808639 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Bladder Cancer and Muscle-invasive Bladder Cancer, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 2
Development phase
39
Enrollment target
4
Study locations

NCT00808639: Completed Phase 2 study of Bladder Cancer and Muscle-invasive Bladder Cancer, sponsored by Dana-Farber Cancer Institute.

NCT00808639 is a Phase 2 study of Bladder Cancer and Muscle-invasive Bladder Cancer that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 39 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00808639, a Phase 2 study of Bladder Cancer and Muscle-invasive Bladder Cancer, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase
39 participants
Enrollment target
4
Study locations

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.

Primary Outcome

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

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
Dana-Farber Cancer Institute

781 total trials

What the finished NCT00808639 record still lists

NCT00808639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).

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.

NCT00808639 reports a single indexed study location in Massachusetts, Pennsylvania.

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.

What interventions are being tested in trial NCT00808639?

The interventions under investigation include: Doxorubicin (DRUG), Methotrexate (DRUG), cisplatin (DRUG), Pegfilgrastim (DRUG), vinblastine (DRUG).

Who is sponsoring clinical trial NCT00808639?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Bladder Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00808639's enrollment target sits among peer trials

39 128th of 175 higher than 48 of 175 other Bladder Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00808639, the US trial registry maintained by the National Library of Medicine. NCT00808639 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.