Trial · NCT00157573
GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer
NCT00157573, Phase 2, Completed, Massachusetts General Hospital; results first posted 2017-05-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer. Trials, record NCT00157573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00157573
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer
- NCT number
- NCT00157573
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer
- Interventions
- GM-CSF, sargramostim
- First posted
- 2005-09-12
- Last updated
- 2017-05-08
- Results first posted
- 2017-05-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Time to Treatment Termination (TTT) | Up to 460 days | TTT is the median time in days to discontinuing treatment with GM-CSF, sargramostim (treatment termination) e.g. time on study until progression of disease, unacceptable adverse effects, bowel obstruction, development of new ascites or pleural effusions, initiation of systemic chemotherapy, participant death, development of co-morbid diseases which make participant continuation on the trial unsafe in the judgment of the principal investigator or the treating physician or withdrawal of consent by the participant. |
| Secondary | Median Time to Progression (TTP) | Up to 60 months | TTP was defined as the median time in days from trial entry until progressive disease (PD) was documented as defined by RECIST criteria. PD was defined of at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In participants with no measurable disease who had an informative cancer antigen-125 (CA-125), PD was defined as a rise of \> 50% over Baseline, confirmed by a subsequently higher value at least 21 days later. |
| Secondary | Tumor Response Rate (RR) | Up to 60 months | RR is the percentage of patients with response as assessed by the investigator using Response Evaluable Criteria in Solid Tumors (RECIST) and CA-125 Rustin criteria. Complete Response (CR) is the disappearance of all target and non-target lesions and normalization of CA-125. Partial Response (PR) is at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; in patients with no measurable disease with an informative CA-125, the 75% definitions by Rustin is used. Stable Disease is neither sufficient shrinkage for PR nor increase for PD, taking as reference the smallest sum LD since the treatment start. PD is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment start or the appearance of one or more new lesions; in patients with no measurable disease with an informative CA-125, PD is defined as a rise of \> 50% over baseline, confirmed by a higher value 21 days later. |
| Secondary | Number of Participants With Adverse Events (Toxicity) Grade 3 or 4 | Up to 460 days | Adverse Events (previously toxicity) were graded according the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. The total number of participants with adverse events graded 3 (severe) or 4 (life-threatening or disabling) are reported. |
| Other | Change From Baseline of Anti-Trag Antibodies | Up to 60 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 | Median Time to Treatment Termination (TTT) | Up to 460 days | After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the actual white cell count (WCC) was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis. | days | MEDIAN |
| SECONDARY | Median Time to Progression (TTP) | Up to 60 months | No analysis was performed. No data was reported for TTP in the clinical chart that was found to be reliable or consistent in the absence of proper computed tomography (CT) surveillance. | ||
| SECONDARY | Tumor Response Rate (RR) | Up to 60 months | After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the actual WCC was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events (Toxicity) Grade 3 or 4 | Up to 460 days | After initial analysis, it was clear that the schedule did not significantly impact the immune response and that the WCC was the best correlate predictor of change in CA125, and so the cohorts were combined for an overall analysis. 1 participant withdrew consent and was not included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline of Anti-Trag Antibodies | Up to 60 months | This outcome measure was originally posted as a secondary outcome measures but was actually an exploratory endpoint. No data was collected. |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Time to Treatment Termination (TTT) | GM-CSF, Sargramostim | 78 | Full Range 14 to 460 | days | |
| Tumor Response Rate (RR) | GM-CSF, Sargramostim | Complete Response | 1 | Participants | |
| Tumor Response Rate (RR) | GM-CSF, Sargramostim | Partial Response | 0 | Participants | |
| Tumor Response Rate (RR) | GM-CSF, Sargramostim | Stable Disease | 20 | Participants | |
| Tumor Response Rate (RR) | GM-CSF, Sargramostim | Progressive Disease | 50 | Participants | |
| Number of Participants With Adverse Events (Toxicity) Grade 3 or 4 | GM-CSF, Sargramostim | Thrombocytopenia | 2 | Participants | |
| Number of Participants With Adverse Events (Toxicity) Grade 3 or 4 | GM-CSF, Sargramostim | Musculoskeletal pain | 9 | Participants | |
| Number of Participants With Adverse Events (Toxicity) Grade 3 or 4 | GM-CSF, Sargramostim | Fatigue | 3 | Participants | |
| Number of Participants With Adverse Events (Toxicity) Grade 3 or 4 | GM-CSF, Sargramostim | Abnormal liver function test | 2 | Participants | |
| Number of Participants With Adverse Events (Toxicity) Grade 3 or 4 | GM-CSF, Sargramostim | Vomiting | 2 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GM-CSF, Sargramostim Cohort 1 | 35 | |
| Overall Study | STARTED | GM-CSF, Sargramostim Cohort 2 | 37 | |
| Overall Study | COMPLETED | GM-CSF, Sargramostim Cohort 1 | 35 | |
| Overall Study | COMPLETED | GM-CSF, Sargramostim Cohort 2 | 37 | |
| Overall Study | NOT COMPLETED | GM-CSF, Sargramostim Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | GM-CSF, Sargramostim Cohort 2 | 0 |
Source ClinicalTrials.gov
Adverse events124
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 | Allergic reaction | Skin and subcutaneous tissue disorders | GM-CSF, Sargramostim Cohort 1 | 35 | 35 | |
| other | Allergic reaction | Skin and subcutaneous tissue disorders | GM-CSF, Sargramostim Cohort 2 | 36 | 37 | |
| other | Hemoglobin | Blood and lymphatic system disorders | GM-CSF, Sargramostim Cohort 1 | 2 | 35 | |
| other | Hemoglobin | Blood and lymphatic system disorders | GM-CSF, Sargramostim Cohort 2 | 0 | 37 | |
| other | Leukocytes | Blood and lymphatic system disorders | GM-CSF, Sargramostim Cohort 1 | 3 | 35 | |
| other | Leukocytes | Blood and lymphatic system disorders | GM-CSF, Sargramostim Cohort 2 | 1 | 37 | |
| other | Lymphopenia | Blood and lymphatic system disorders | GM-CSF, Sargramostim Cohort 1 | 2 | 35 | |
| other | Lymphopenia | Blood and lymphatic system disorders | GM-CSF, Sargramostim Cohort 2 | 1 | 37 | |
| other | Fatigue | General disorders | GM-CSF, Sargramostim Cohort 1 | 35 | 35 | |
| other | Fatigue | General disorders | GM-CSF, Sargramostim Cohort 2 | 19 | 37 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GM-CSF, Sargramostim Cohort 1 | ||
| Total, all-cause mortality | GM-CSF, Sargramostim Cohort 2 | ||
| Total, other adverse events | GM-CSF, Sargramostim Cohort 1 | 35 | 35 |
| Total, other adverse events | GM-CSF, Sargramostim Cohort 2 | 37 | 37 |
| Total, serious adverse events | GM-CSF, Sargramostim Cohort 1 | 2 | 35 |
| Total, serious adverse events | GM-CSF, Sargramostim Cohort 2 | 5 | 37 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19922985 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| GM-CSF, Sargramostim Cohort 1 vs GM-CSF, Sargramostim Cohort 2: serious adverse events |
Source Trial comparisons
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/NCT00157573
GET https://conductscience.org/api/trials/v1/NCT00157573/results?page=2