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NCT00506155 · ClinicalTrials.gov registry record · Phase 2

Neoadjuvant Chemotherapy With Methotrexate, Vinblastine, Adriamycin and Cisplatin (M-VAC) Plus Avastin in Patients With Urothelial Cancer

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target

NCT00506155: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00506155 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00506155, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target

Study Summary

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. Primary Objective: 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.) Secondary Objective: 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.

Primary Outcome

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

Interventions

  • DRUG Cisplatin
  • DRUG Doxorubicin
  • DRUG Methotrexate
  • DRUG Vinblastine Sulfate
  • DRUG Avastin

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2007-06
Est. Completion 2014-08
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00506155 record still lists

NCT00506155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.

NCT00506155 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00506155 about?

NCT00506155 is a clinical study titled "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. Primary Objective: To estimate the response of patients with locally a...

What is the current status of trial NCT00506155?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2007-06. Estimated completion is 2014-08.

What interventions are being tested in trial NCT00506155?

The interventions under investigation include: Cisplatin (DRUG), Doxorubicin (DRUG), Methotrexate (DRUG), Vinblastine Sulfate (DRUG), Avastin (DRUG).

Who is sponsoring clinical trial NCT00506155?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT00506155's enrollment target sits among peer trials

60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00506155, the US trial registry maintained by the National Library of Medicine. NCT00506155 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.