Trial · NCT00095979
Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer
NCT00095979, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-05-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer. Trials, record NCT00095979. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00095979
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer
- NCT number
- NCT00095979
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Endometrial Adenocarcinoma, Recurrent Endometrial Carcinoma, Stage IV Endometrial Carcinoma
- Interventions
- ixabepilone
- First posted
- 2004-11-09
- Last updated
- 2019-07-24
- Results first posted
- 2015-05-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response | Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease | RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate. |
| Primary | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months) | |
| Secondary | Progression-free Survival | From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up. | Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. |
| Secondary | Overall Survival | From study entry to death or last contact, up to 5 years of follow-up. | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response | Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease | Eligible and Treated Patients | percentage of participants | NUMBER |
| PRIMARY | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months) | Eligible and treated patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival | From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up. | Eligible and Treated Patients | months | MEDIAN |
| SECONDARY | Overall Survival | From study entry to death or last contact, up to 5 years of follow-up. | Eligible and treated patients | months | MEDIAN |
Source ClinicalTrials.gov
Results by group123
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response | Ixabepilone | 12 | 90% Confidence Interval 7 to 100 | percentage of participants | |
| Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Grade 1 | Leukopenia | 9 | Participants | |
| Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Grade 2 | Leukopenia | 14 | Participants | |
| Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Grade 3 | Leukopenia | 17 | Participants | |
| Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Grade 4 | Leukopenia | 7 | Participants | |
| Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Grade 5 | Leukopenia | 0 | Participants | |
| Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Grade 1 | Neutropenia | 5 | Participants | |
| Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Grade 2 | Neutropenia | 7 | Participants | |
| Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Grade 3 | Neutropenia | 14 | Participants | |
| Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Grade 4 | Neutropenia | 12 | Participants |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ixabepilone | 52 | |
| Overall Study | COMPLETED | Ixabepilone | 50 | |
| Overall Study | NOT COMPLETED | Ixabepilone | 2 |
Source ClinicalTrials.gov
Adverse events171
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 | Immune system disorders | Ixabepilone | 2 | 50 | |
| other | Rhinitis | Immune system disorders | Ixabepilone | 4 | 50 | |
| other | Hearing (Without Monitoring Program) | Ear and labyrinth disorders | Ixabepilone | 1 | 50 | |
| other | Tinnitus | Ear and labyrinth disorders | Ixabepilone | 2 | 50 | |
| other | Neutrophils | Blood and lymphatic system disorders | Ixabepilone | 36 | 50 | |
| other | Platelets | Blood and lymphatic system disorders | Ixabepilone | 20 | 50 | |
| other | Leukocytes | Blood and lymphatic system disorders | Ixabepilone | 47 | 50 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Ixabepilone | 1 | 50 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Ixabepilone | 48 | 50 | |
| other | Supraventricular Tachycardia | Cardiac disorders | Ixabepilone | 1 | 50 |
1 to 10 of 171Source ClinicalTrials.gov
See all 171 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ixabepilone | ||
| Total, other adverse events | Ixabepilone | 50 | 50 |
| Total, serious adverse events | Ixabepilone | 25 | 50 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
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/NCT00095979
GET https://conductscience.org/api/trials/v1/NCT00095979/results?page=2