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NCT00655850 · ClinicalTrials.gov registry record · Phase 2

Lower Dose Chemotherapy Given More Frequent With Avastin to Treat Advanced Non-Squamous Non-Small Cell Lung Cancer

A Phase 2 study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 2
Development phase
39
Enrollment target

NCT00655850: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.

NCT00655850 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00655850, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 2
Development phase
39 participants
Enrollment target

Study Summary

This study is being done to determine the overall progression-free survival (PFS) in patients with advanced or metastatic (Stage IIIB - pleural effusion/IV), non-squamous histology NSCLC treated with metronomic chemotherapy plus Avastin. Also, currently there are no defined markers that predict for clinical benefit to Avastin. Preliminary studies show that there are several observations that support the concept of metronomic chemotherapy with or without the combination of an anti-angiogenic agent. The metronomic chemotherapy with Avastin was shown to enhance the clinical endpoints of the study (response rate and progressive-free survival). Proof of metronomic scheduling requires the development of appropriate intermediate surrogate markers. Several markers will be assessed.

Primary Outcome

Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences disease progression in accordance with the Response Evaluation Criteria Solid Tumors (RECIST v1.0). The RECIST criteria indicates progression as a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.

Interventions

  • DRUG Paclitaxel
  • DRUG Gemcitabine
  • BIOLOGICAL Avastin

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2008-03
Est. Completion 2016-09
Phase Phase 2
University of Alabama at Birmingham

1,160 total trials

What the finished NCT00655850 record still lists

NCT00655850 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 3 interventions - of which Paclitaxel is the first listed.

NCT00655850 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00655850 about?

NCT00655850 is a clinical study titled "Lower Dose Chemotherapy Given More Frequent With Avastin to Treat Advanced Non-Squamous Non-Small Cell Lung Cancer". This study is being done to determine the overall progression-free survival (PFS) in patients with advanced or metastatic (Stage IIIB - pleural effusion/IV), non-squamous histology NSCLC treated with metronomic chemotherapy plus Avastin. Also, currently there are no defined markers that predict for ...

What is the current status of trial NCT00655850?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2008-03. Estimated completion is 2016-09.

What interventions are being tested in trial NCT00655850?

The interventions under investigation include: Paclitaxel (DRUG), Gemcitabine (DRUG), Avastin (BIOLOGICAL).

Who is sponsoring clinical trial NCT00655850?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00655850's enrollment target sits among peer trials

39 1459th of 2000 higher than 534 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 NCT00655850, the US trial registry maintained by the National Library of Medicine. NCT00655850 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.