Trial · NCT00466960
Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy
NCT00466960, Phase 2, Completed, University of Washington; results first posted 2017-08-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy. Trials, record NCT00466960. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00466960
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy
- NCT number
- NCT00466960
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- University of Washington
- Conditions
Brenner Tumor, Fallopian Tube Cancer, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Epithelial Carcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer
- Interventions
- sargramostim, paclitaxel albumin-stabilized nanoparticle formulation, laboratory biomarker analysis, immunologic technique
- First posted
- 2007-04-27
- Last updated
- 2017-08-28
- Results first posted
- 2017-08-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Progression | Up to 5 years | Median time to progression |
| Primary | Response Rate | Up to 5 years | Number of patients achieving a complete or partial response. |
| Secondary | Correlation Between Circulating Monocytes and Time to Progression | Up to 5 years | Baseline median percentages of CD45+ cells made up of monocytes in complete responders (CR) compared to partial-responders, non-responders and those with stable disease (PR+NR+SD). |
| Secondary | Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration | Up to 5 years | Baseline median percentages of CD45+ cells made up of myeloid dendritic cells (mDC) and plasmacytoid dendritic cells (pDC) in complete responders (CR) compared to partial and non-responders (PR+NR+SD). |
| Secondary | Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens | Up to 5 years | Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up. |
| Secondary | Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens | Up to 5 years | Correlation of time to progression and change in circulating activated T lymphocytes from baseline to follow-up. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Progression | Up to 5 years | months | MEDIAN | |
| PRIMARY | Response Rate | Up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Correlation Between Circulating Monocytes and Time to Progression | Up to 5 years | percentage of CD45+ in PBSC | MEDIAN | |
| SECONDARY | Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration | Up to 5 years | % of CD45+PBMC | MEDIAN | |
| SECONDARY | Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens | Up to 5 years | Pearson correlation | NUMBER | |
| SECONDARY | Precursor Frequency of Circulating T Lymphocytes Activated Against Foreign Antigens | Up to 5 years | Pearson correlation | NUMBER |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Progression | Treatment (Colony Stimulating Factor and Chemotherapy) | 4.07 | 95% Confidence Interval 2.74 to 6.71 | months | |
| Response Rate | Treatment (Colony Stimulating Factor and Chemotherapy) | 15 | Participants | ||
| Correlation Between Circulating Monocytes and Time to Progression | Treatment (Colony Stimulating Factor and Chemotherapy) | CR | 20.75 | Inter-Quartile Range 10.98 to 24.93 | percentage of CD45+ in PBSC |
| Correlation Between Circulating Monocytes and Time to Progression | Treatment (Colony Stimulating Factor and Chemotherapy) | PR+NR+SD | 12.75 | Inter-Quartile Range 11.24 to 30.1 | percentage of CD45+ in PBSC |
| Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration | Treatment (Colony Stimulating Factor and Chemotherapy) | mDC in CR | 1.543 | Inter-Quartile Range 1.075 to 3.504 | % of CD45+PBMC |
| Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration | Treatment (Colony Stimulating Factor and Chemotherapy) | mDC in PR+NR+SD | 1.996 | Inter-Quartile Range 1.232 to 2.42 | % of CD45+PBMC |
| Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration | Treatment (Colony Stimulating Factor and Chemotherapy) | pDC in CR | 0.2465 | Inter-Quartile Range 0.1924 to 0.3362 | % of CD45+PBMC |
| Correlation Between Circulating Dendritic Cell Count and Maturation State With Clinical Response and Response Duration | Treatment (Colony Stimulating Factor and Chemotherapy) | pDC in PR+NR+SD | 0.3743 | Inter-Quartile Range 0.2311 to 0.5067 | % of CD45+PBMC |
| Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens | Treatment (Colony Stimulating Factor and Chemotherapy) | IGF1R-p1196-1210 | 0.5056 | 95% Confidence Interval -0.03429 to 0.8171 | Pearson correlation |
| Precursor Frequency of Circulating Activated T Lymphocytes Against Common Ovarian Cancer Tumor Associated Antigens to Measure the Development of Immunity to Anti-tumor Antigens | Treatment (Colony Stimulating Factor and Chemotherapy) | IGF1R-p1242-1256 | 0.8496 | 95% Confidence Interval 0.5807 to 0.9513 | Pearson correlation |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Colony Stimulating Factor and Chemotherapy) | 21 | |
| Overall Study | COMPLETED | Treatment (Colony Stimulating Factor and Chemotherapy) | 21 | |
| Overall Study | NOT COMPLETED | Treatment (Colony Stimulating Factor and Chemotherapy) | 0 |
Source ClinicalTrials.gov
Adverse events50
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/Hypersensitivity (Including drug fever) | Immune system disorders | Treatment (Colony Stimulating Factor and Chemotherapy) | 2 | 21 | |
| other | Tinnitus | Ear and labyrinth disorders | Treatment (Colony Stimulating Factor and Chemotherapy) | 2 | 21 | |
| other | Low HCT | Blood and lymphatic system disorders | Treatment (Colony Stimulating Factor and Chemotherapy) | 2 | 21 | |
| other | Hematocrit | Blood and lymphatic system disorders | Treatment (Colony Stimulating Factor and Chemotherapy) | 3 | 21 | |
| other | RBC | Blood and lymphatic system disorders | Treatment (Colony Stimulating Factor and Chemotherapy) | 2 | 21 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Treatment (Colony Stimulating Factor and Chemotherapy) | 13 | 21 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Treatment (Colony Stimulating Factor and Chemotherapy) | 11 | 21 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Treatment (Colony Stimulating Factor and Chemotherapy) | 6 | 21 | |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Treatment (Colony Stimulating Factor and Chemotherapy) | 6 | 21 | |
| other | Platelets | Blood and lymphatic system disorders | Treatment (Colony Stimulating Factor and Chemotherapy) | 2 | 21 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Colony Stimulating Factor and Chemotherapy) | ||
| Total, other adverse events | Treatment (Colony Stimulating Factor and Chemotherapy) | 20 | 21 |
| Total, serious adverse events | Treatment (Colony Stimulating Factor and Chemotherapy) | 2 | 21 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00466960
GET https://conductscience.org/api/trials/v1/NCT00466960/events?page=2