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NCT00001338 · ClinicalTrials.gov registry record · Phase 3
A Prospective, Randomized, Phase III Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Chemotherapy With GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) Versus PIXY 321 in Advanced Breast Cancer
A Phase 3 study of Breast Neoplasms and Sepsis, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT00001338 is a Phase 3 study of Breast Neoplasms and Sepsis that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 65 participants, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001338, a Phase 3 study of Breast Neoplasms and Sepsis, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, randomized Phase III trial of FLAC chemotherapy with GM-CSF versus PIXY321 in advanced breast cancer. The primary endpoints of this study will be the duration of thrombocytopenia and the time to recovery of platelets to 50,000/microliters. Other clinical endpoints will include the depth and duration of leukopenia, neutropenia, and anemia, the platelet and RBC transfusion requirements, and the number of documented instances of sepsis and hospitalizations for fever and neutropenia. Laboratory correlates will include the detailed evaluation of the effects on circulating hematopoietic progenitor cells by GM-CSF and PIXY321 and the potential effects these agents have on the bone marrow micro-environment. After 5 cycles of FLAC with GM-CSF versus PIXY321, patients will be treated with 5 cycles of 96 hour infusional taxol. The goal of this part of the study will be to assess the toxicity and feasibility of administering infusional taxol following dose-intensive FLAC chemotherapy.
Conditions Studied
Interventions
- DRUG FLAC chemotherapy with GM-CSF
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 1993-06 |
| Est. Completion | 2001-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001338
The ClinicalTrials.gov registry entry for NCT00001338 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (89% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which FLAC chemotherapy with GM-CSF is the first listed.
NCT00001338 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001338 about?
NCT00001338 is a clinical study titled "A Prospective, Randomized, Phase III Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Chemotherapy With GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) Versus PIXY 321 in Advanced Breast Cancer". This is a prospective, randomized Phase III trial of FLAC chemotherapy with GM-CSF versus PIXY321 in advanced breast cancer. The primary endpoints of this study will be the duration of thrombocytopenia and the time to recovery of platelets to 50,000/microliters. Other clinical endpoints will include...
What is the current status of trial NCT00001338?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 1993-06. Estimated completion is 2001-01.
What conditions does trial NCT00001338 study?
This clinical trial studies the following conditions: Breast Neoplasms, Sepsis, Fever, Hematologic Diseases, Neutropenia.
What interventions are being tested in trial NCT00001338?
The interventions under investigation include: FLAC chemotherapy with GM-CSF (DRUG).
Who is sponsoring clinical trial NCT00001338?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001338 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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