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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. According to ClinicalTrials.gov, the official US trial registry.

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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

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00001384

The ClinicalTrials.gov registry entry for NCT00001384 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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

NCT00001384 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.