Trial · NCT00114218
Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer
NCT00114218, Phase 2, Completed, Gynecologic Oncology Group; results first posted 2018-10-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer. Trials, record NCT00114218. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00114218
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer
- NCT number
- NCT00114218
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Gynecologic Oncology Group
- Conditions
- Recurrent Uterine Corpus Sarcoma, Uterine Carcinosarcoma
- Interventions
- Gemcitabine Hydrochloride, Docetaxel
- First posted
- 2005-06-14
- Last updated
- 2019-01-08
- Results first posted
- 2018-10-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0 | CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years. | 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 | Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Assessed every 28 days (28 days=1 cycle) while on study treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up | Count of participants with Toxicities maximum grade greater than or equal to grade 3 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0 | CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years. | Eligible and Treated patients | Percentage of participants | NUMBER |
| PRIMARY | Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Assessed every 28 days (28 days=1 cycle) while on study treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up | Eligible and Treated patients | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0 | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 8 | 95% Confidence Interval 1 to 27 | Percentage of participants | |
| Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 18 | 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 | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 28 | |
| Overall Study | COMPLETED | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 24 | |
| Overall Study | NOT COMPLETED | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 4 |
Source ClinicalTrials.gov
Adverse events40
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 | Leukopenia | Blood and lymphatic system disorders | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 18 | 24 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 15 | 24 | |
| other | Neutropenia | Blood and lymphatic system disorders | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 18 | 24 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 20 | 24 | |
| other | Nausea | Gastrointestinal disorders | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 11 | 24 | |
| other | Other Gastrointestinal | Gastrointestinal disorders | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 14 | 24 | |
| other | Genitourinary | Renal and urinary disorders | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 2 | 24 | |
| other | Neurotoxicity | Nervous system disorders | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 6 | 24 | |
| other | Pain | General disorders | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 4 | 24 | |
| other | Pulmonary | Respiratory, thoracic and mediastinal disorders | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 3 | 24 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Gemcitabine Hydrochloride, Docetaxel) | ||
| Total, other adverse events | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 22 | 24 |
| Total, serious adverse events | Treatment (Gemcitabine Hydrochloride, Docetaxel) | 11 | 24 |
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/NCT00114218
GET https://conductscience.org/api/trials/v1/NCT00114218/events?page=2