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NCT00001384 · ClinicalTrials.gov registry record · Phase 2

A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy With G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
35
Enrollment target

NCT00001384: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00001384 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00001384, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
35 participants
Enrollment target

Study Summary

This is a pilot feasibility trial of AC (Adriamycin, cyclophosphamide) chemotherapy with G-CSF (filgrastim) followed by infusional Taxol (paclitaxel) as adjuvant treatment for patients with high risk stage II and stage III breast cancer. Cycles will be 14 days in duration. After 3 fourteen day cycles of AC with filgrastim, patients will be treated with 3 fourteen day cycles of 96 hour infusional paclitaxel. The goal of this study will be to assess the toxicity and feasibility of administering dose-intensive AC chemotherapy followed by infusional paclitaxel in 14 day cycles.

Interventions

  • DRUG G-CSF
  • DRUG cyclophosphamide
  • DRUG paclitaxel
  • DRUG Adriamycin

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 1994-05
Est. Completion 2001-02
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00001384 record still lists

NCT00001384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 4 interventions - of which G-CSF is the first listed.

NCT00001384 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001384 about?

NCT00001384 is a clinical study titled "A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy With G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients". This is a pilot feasibility trial of AC (Adriamycin, cyclophosphamide) chemotherapy with G-CSF (filgrastim) followed by infusional Taxol (paclitaxel) as adjuvant treatment for patients with high risk stage II and stage III breast cancer. Cycles will be 14 days in duration. After 3 fourteen day cycle...

What is the current status of trial NCT00001384?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 1994-05. Estimated completion is 2001-02.

What interventions are being tested in trial NCT00001384?

The interventions under investigation include: G-CSF (DRUG), cyclophosphamide (DRUG), paclitaxel (DRUG), Adriamycin (DRUG).

Who is sponsoring clinical trial NCT00001384?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00001384's enrollment target sits among peer trials

35 1524th of 2000 higher than 462 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 NCT00001384, the US trial registry maintained by the National Library of Medicine. NCT00001384 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.