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NCT00662129 · ClinicalTrials.gov registry record · Phase 2

Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

A Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target

NCT00662129: Completed Phase 2 study, sponsored by Alliance for Clinical Trials in Oncology.

NCT00662129 is a Phase 2 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00662129, a Phase 2 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine together with bevacizumab works in treating patients with metastatic breast cancer.

Primary Outcome

The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is 6 months from registration without a documentation of disease progression (note, the patient need not be on study treatment at 6 months to be considered a success). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success pro

Interventions

  • DRUG paclitaxel albumin-stabilized nanoparticle formulation
  • BIOLOGICAL bevacizumab
  • DRUG gemcitabine hydrochloride

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2008-11
Est. Completion 2013-08
Phase Phase 2

What the finished NCT00662129 record still lists

NCT00662129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 3 interventions - of which paclitaxel albumin-stabilized nanoparticle formulation is the first listed.

NCT00662129 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00662129 about?

NCT00662129 is a clinical study titled "Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor ...

What is the current status of trial NCT00662129?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2008-11. Estimated completion is 2013-08.

What interventions are being tested in trial NCT00662129?

The interventions under investigation include: paclitaxel albumin-stabilized nanoparticle formulation (DRUG), bevacizumab (BIOLOGICAL), gemcitabine hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00662129?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00662129's enrollment target sits among peer trials

50 1195th of 2000 higher than 740 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 NCT00662129, the US trial registry maintained by the National Library of Medicine. NCT00662129 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.