Trial · NCT00501644
Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer
NCT00501644, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2011-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer. Trials, record NCT00501644. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00501644
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer
- NCT number
- NCT00501644
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Interventions
- Carboplatin, GM-CSF (Sargramostim), Interferon Gamma
- First posted
- 2007-07-16
- Last updated
- 2012-08-07
- Results first posted
- 2011-01-10
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Response | Follow up CT scans after every 3 courses of treatment and following completion of all treatments. | Per World Health Organization (WHO) Tumor Response: Complete Response (CR), Partial Response (PR) or Progressive Disease (PD). CR defined as disappearance of all target lesions, PR as \> = 30% decrease in sum of longest dimensions of target lesions with reference baseline sum longest dimensions and if CA 125 levels declined by \>50%, provided target lesion size did not increase by \>20% on imaging, and PD as \>20% increase in sum of longest dimensions of target lesions taking as references smallest sum of longest dimensions recorded since treatment started, or appearance of 1 or \> new lesions. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Response | Follow up CT scans after every 3 courses of treatment and following completion of all treatments. | Analysis per protocol. Of 59 participants enrolled, five (5) were not evaluable. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Response | Chemoimmunotherapy | Complete Response | 9 | Participants | |
| Number of Patients With Response | Chemoimmunotherapy | Partial Response | 21 | Participants | |
| Number of Patients With Response | Chemoimmunotherapy | Progressive Disease | 24 | Participants |
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 | Chemoimmunotherapy | 59 | |
| Overall Study | COMPLETED | Chemoimmunotherapy | 54 | |
| Overall Study | NOT COMPLETED | Chemoimmunotherapy | 5 |
Source ClinicalTrials.gov
Adverse events11
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 |
|---|---|---|---|---|---|---|
| serious | Neutrophil count decreased | Investigations | Chemoimmunotherapy | 16 | 54 | 16 |
| serious | Platelet count decreased | Investigations | Chemoimmunotherapy | 9 | 54 | 9 |
| serious | Anemia | Blood and lymphatic system disorders | Chemoimmunotherapy | 2 | 54 | 2 |
| serious | Fatigue | General disorders | Chemoimmunotherapy | 20 | 54 | 20 |
| serious | Infusion related reaction | General disorders | Chemoimmunotherapy | 15 | 54 | 15 |
| serious | Myalgia | Musculoskeletal and connective tissue disorders | Chemoimmunotherapy | 10 | 54 | 10 |
| serious | Depression/Anxiety | Psychiatric disorders | Chemoimmunotherapy | 8 | 54 | 8 |
| serious | Nausea | Gastrointestinal disorders | Chemoimmunotherapy | 5 | 54 | 5 |
| serious | Headache | Nervous system disorders | Chemoimmunotherapy | 2 | 54 | 2 |
| serious | Peripheral Sensory Neuropathy | Nervous system disorders | Chemoimmunotherapy | 3 | 54 | 3 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemoimmunotherapy | ||
| Total, other adverse events | Chemoimmunotherapy | 0 | 54 |
| Total, serious adverse events | Chemoimmunotherapy | 20 | 54 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00501644
GET https://conductscience.org/api/trials/v1/NCT00501644/registered