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NCT00194753 · ClinicalTrials.gov registry record · Phase 2
Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin & Oral Cytoxan With G-CSF for 12 Wks; Wkly Taxol x 12
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT00194753 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 80 participants.
The verdict
NCT00194753, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
The primary objectives of the study are to evaluate the feasibility and toxicity of treatment with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks of Taxol. Feasibility will be assessed by comparing the delivered dose intensity of each drug to the delivered dose intensity in previous trials. Toxicity will be assessed by comparing the incidence and severity of toxicity with these drugs to previous trials using these drugs in the same combination. We hypothesize metronomic, dose dense treatment as given in this study will be less toxic and more effective than historical regimens using the same drugs in a less metronomic, dose dense manner.
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG G-CSF
- DRUG Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2001-12 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00194753
The ClinicalTrials.gov registry entry for NCT00194753 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT00194753 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00194753 about?
NCT00194753 is a clinical study titled "Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin & Oral Cytoxan With G-CSF for 12 Wks; Wkly Taxol x 12". The primary objectives of the study are to evaluate the feasibility and toxicity of treatment with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks of Taxol. Feasibility will be assessed by comparing the delivered dose intensity of each drug to the delivered dos...
What is the current status of trial NCT00194753?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2001-12. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00194753?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), G-CSF (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00194753?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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