Trial · NCT00274287
GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere
NCT00274287, Phase 2, Completed, Oncology Specialists, S.C.; results first posted 2012-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere. Trials, record NCT00274287. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00274287
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere
- NCT number
- NCT00274287
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Oncology Specialists, S.C.
- Conditions
- Prostate Cancer
- Interventions
- GM CSF
- First posted
- 2006-01-10
- Last updated
- 2019-03-28
- Results first posted
- 2012-05-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Disease Progression (TTP) | up to 21 months | The primary end point of this study is to evaluate time to disease progression (TTP). TTP is defined as the time from starting taxotere until there is evidence of progressive disease (PD) as defined below (radiographically and/or biochemically). PD was defined as more than 20% in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Median TTP from GM-CSF administration and Median TTP from start of chemotherapy is being reported |
| Secondary | Response Rate (PSA) | up to 21 months | Biochemical PR (Partial Response) was defined as a PSA that decreases by 50% and maintains by at least 3 weeks by confirmatory measurement. Biochemical SD (stable disease) was defined as a PSA that was increased by less than 25% or decreased by less than 50% Biochemical PD (progressive disease) was defined as an increase of at least 25% confirmed 3 weeks after. |
| Secondary | Response Rate (Radiographic) | up to 21 months | PR was defined as more than 30% decrease in the sum of the longest diameter of measurable lesions compared to baseline. SD was defined when lesions did not meet criteria for PR or PD. PD was defined as more than 20% increase in the sum of the longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions at imaging studies. The appearance of 2 or more new boney lesions on bone scan development of cord compression, and pathologic fractures constituted PD. |
| Secondary | Median Overall Survival (OS) | up to 44 months | |
| Secondary | Median Number of GM-CSF Cycles | up to 12 months |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Disease Progression (TTP) | up to 21 months | all evaluable participants | months | MEDIAN |
| SECONDARY | Response Rate (PSA) | up to 21 months | all evaluable participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response Rate (Radiographic) | up to 21 months | all evaluable participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Overall Survival (OS) | up to 44 months | all evaluable participants | months | MEDIAN |
| SECONDARY | Median Number of GM-CSF Cycles | up to 12 months | all evaluable participants | months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Disease Progression (TTP) | GM-CSF (Leukine) | TTP from GM-CSF | 6 | Full Range 2 to 12 | months |
| Time to Disease Progression (TTP) | GM-CSF (Leukine) | TTP from chemotherapy | 11 | Full Range 9 to 21 | months |
| Response Rate (PSA) | GM-CSF (Leukine) | PSA PD | 7 | Participants | |
| Response Rate (PSA) | GM-CSF (Leukine) | PSA PR | 2 | Participants | |
| Response Rate (PSA) | GM-CSF (Leukine) | PSA SD | 4 | Participants | |
| Response Rate (Radiographic) | GM-CSF (Leukine) | Radiographic PD | 4 | Participants | |
| Response Rate (Radiographic) | GM-CSF (Leukine) | Radiographic SD | 9 | Participants | |
| Median Overall Survival (OS) | GM-CSF (Leukine) | OS from GM-CSF | 12 | Full Range 2 to 38 | months |
| Median Overall Survival (OS) | GM-CSF (Leukine) | OS from chemotherapy | 21 | Full Range 10 to 44 | months |
| Median Number of GM-CSF Cycles | GM-CSF (Leukine) | 6 | Full Range 2 to 12 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GM-CSF (Leukine) | 15 | |
| Overall Study | COMPLETED | GM-CSF (Leukine) | 13 | |
| Overall Study | NOT COMPLETED | GM-CSF (Leukine) | 2 |
Source ClinicalTrials.gov
Adverse events98
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | albumin low | Blood and lymphatic system disorders | GM-CSF (Leukine) | 6 | 15 | 6 |
| other | alk phos | Blood and lymphatic system disorders | GM-CSF (Leukine) | 4 | 15 | 4 |
| other | alopecia | General disorders | GM-CSF (Leukine) | 3 | 15 | 3 |
| other | anorexia | Metabolism and nutrition disorders | GM-CSF (Leukine) | 4 | 15 | 4 |
| other | arthralgia | Surgical and medical procedures | GM-CSF (Leukine) | 1 | 15 | 1 |
| other | AST high | Hepatobiliary disorders | GM-CSF (Leukine) | 2 | 15 | 2 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | GM-CSF (Leukine) | 1 | 15 | 1 |
| other | balance difficulty | Nervous system disorders | GM-CSF (Leukine) | 1 | 15 | 1 |
| other | bleeding | Blood and lymphatic system disorders | GM-CSF (Leukine) | 2 | 15 | 2 |
| other | breathing difficult | Respiratory, thoracic and mediastinal disorders | GM-CSF (Leukine) | 1 | 15 | 1 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GM-CSF (Leukine) | ||
| Total, other adverse events | GM-CSF (Leukine) | 7 | 15 |
| Total, serious adverse events | GM-CSF (Leukine) | 7 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23210004 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00274287
GET https://conductscience.org/api/trials/v1/NCT00274287/events?page=2