Trial · NCT00506779
Gleevec/Taxol for Patients With Uterine Papillary Serous Carcinoma
NCT00506779, Phase 1, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2020-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gleevec/Taxol for Patients With Uterine Papillary Serous Carcinoma. Trials, record NCT00506779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00506779
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gleevec/Taxol for Patients With Uterine Papillary Serous Carcinoma
- NCT number
- NCT00506779
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Uterine Cancer
- Interventions
- Imatinib Mesylate, Paclitaxel
- First posted
- 2007-07-25
- Last updated
- 2020-11-18
- Results first posted
- 2020-11-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Evaluated at 3 weeks (one cycle) | Maximum Tolerated Dose (MTD) of Oral Imatinib Mesylate in Combination with Fixed Dose Paclitaxel where MTD of Imatinib Mesylate (mg/m\^2 daily) to be determined with conventional 3+3 design, MTD is highest dose level in which 6 participants treated with at most 2 experiencing dose limiting toxicity (DLT). Study utilizes Common Terminology for Adverse Events Criteria (CTCAE) version 3.0 for adverse event reporting. Following cohorts of 3 at lower dose levels until 1 of 3 patients experiences DLT; if 1 of 3 patients experiences DLT at dose level, enter 3 additional patients at dose level, if only 1 of 6 patients experiences DLT at dose level, proceed to next higher dose level with cohort of 3; If 2 of 3 or 3 of 6 patients experience DLT, MTD has exceeded. Once DLT exceeded, treat another 3 patients at previous dose if there were only 3 patients treated at that dose level. MTD is highest dose level in which treated 6 patients with at most 2 experiencing the DLT. |
| Secondary | Number of Participants With Complete Response | 6 weeks to 18 weeks; Best response achieved since study entry where measurable disease defined as => 1 lesion accurately measured in at least 1 dimension (longest dimension to be recorded) | Complete Response (CR): Disappearance lesions, no evidence new lesions documented by 2 disease assessments\> 4 weeks apart. Partial Response (PR):\>30% decrease in sum longest dimensions (LD) all target measurable lesions reference baseline sum of LD; No progression non-target lesions \& no new lesions; Documentation by 2 disease assessments \>4 weeks apart; Progressive Disease (PD) (ANY of following): \>20% increase in sum LD of target lesions reference smallest sum LD or appearance of new lesions within 8 weeks of study entry; Unequivocal progression on existing non-target lesions, other than pleural effusions without cytological proof of neoplastic origin, within 8 weeks of study entry also considered increasing disease. Death due to disease without prior objective documentation of progression; Global deterioration in health attributable to disease requiring change in therapy without objective evidence of progression. Stable disease: Any condition not meeting above criteria. |
| Secondary | Time to Tumor Progression | Evaluation at at 6 weeks, tumor restaging continued up to 6 cycles (18 weeks) or until disease progression, whichever comes first | Efficacy of Gleevec and Taxol in Participants defined by tumor progression for participants with measurable disease or recurrent non-measurable disease. Time to tumor progression defined as the time from date of initial treatment to first objective documentation of disease progression. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). After two cycles (6 weeks), participants will undergo clinical and radiographic (participants with measurable disease) tumor restaging or confirmation recurrent non-measurable disease. Evaluation of tumor response (for participants who already have the disease) determined by CT scan or MRI and chest x-ray (participants with chest disease). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Evaluated at 3 weeks (one cycle) | One participant of 12 registered withdrew prior to receiving treatment. | participants | NUMBER |
| SECONDARY | Number of Participants With Complete Response | 6 weeks to 18 weeks; Best response achieved since study entry where measurable disease defined as => 1 lesion accurately measured in at least 1 dimension (longest dimension to be recorded) | participants | NUMBER | |
| SECONDARY | Time to Tumor Progression | Evaluation at at 6 weeks, tumor restaging continued up to 6 cycles (18 weeks) or until disease progression, whichever comes first | Due to poor enrollment, the study was terminated early and no data collected for the Time to tumor progression outcome measure. |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Imatinib Mesylate 400 mg | 0 | participants | ||
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Imatinib Mesylate 500 mg | 1 | participants | ||
| Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) | Imatinib Mesylate 600 mg | 2 | participants | ||
| Number of Participants With Complete Response | Participants With Measurable Disease | 1 | participants | ||
| Number of Participants With Complete Response | Participants With Non-Measurable Disease | 7 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I: Imatinib Mesylate 400 mg | 4 | |
| Overall Study | STARTED | Phase I: Imatinib Mesylate 500 mg | 6 | |
| Overall Study | STARTED | Phase I: Imatinib Mesylate 600 mg | 2 | |
| Overall Study | STARTED | Phase II: Imatinib Mesylate MTD 500 mg | 5 | |
| Overall Study | COMPLETED | Phase I: Imatinib Mesylate 400 mg | 3 | |
| Overall Study | COMPLETED | Phase I: Imatinib Mesylate 500 mg | 5 | |
| Overall Study | COMPLETED | Phase I: Imatinib Mesylate 600 mg | 0 | |
| Overall Study | COMPLETED | Phase II: Imatinib Mesylate MTD 500 mg | 4 | |
| Overall Study | NOT COMPLETED | Phase I: Imatinib Mesylate 400 mg | 1 | |
| Overall Study | NOT COMPLETED | Phase I: Imatinib Mesylate 500 mg | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events104
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 | Fever w/o Neutropenia | Blood and lymphatic system disorders | Phase I: Imatinib Mesylate 400mg | 2 | 4 | |
| other | Fever w/o Neutropenia | Blood and lymphatic system disorders | Phase II: Imatinib Mesylate 500 mg | 0 | 6 | |
| other | Fever w/o Neutropenia | Blood and lymphatic system disorders | Phase 1: Imatinib Mesylate 600 mg | 1 | 2 | |
| other | Fever w/o Neutropenia | Blood and lymphatic system disorders | Phase II: Imatinib Mesylate MTD 500 mg | 0 | 5 | |
| other | Fatigue | General disorders | Phase I: Imatinib Mesylate 400mg | 4 | 4 | |
| other | Fatigue | General disorders | Phase II: Imatinib Mesylate 500 mg | 6 | 6 | |
| other | Fatigue | General disorders | Phase 1: Imatinib Mesylate 600 mg | 2 | 2 | |
| other | Fatigue | General disorders | Phase II: Imatinib Mesylate MTD 500 mg | 3 | 5 | |
| other | Neuropathy | Nervous system disorders | Phase I: Imatinib Mesylate 400mg | 3 | 4 | |
| other | Neuropathy | Nervous system disorders | Phase II: Imatinib Mesylate 500 mg | 3 | 6 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I: Imatinib Mesylate 400mg | 0 | 4 |
| Total, all-cause mortality | Phase II: Imatinib Mesylate 500 mg | 0 | 6 |
| Total, all-cause mortality | Phase 1: Imatinib Mesylate 600 mg | 0 | 2 |
| Total, all-cause mortality | Phase II: Imatinib Mesylate MTD 500 mg | 0 | 5 |
| Total, other adverse events | Phase I: Imatinib Mesylate 400mg | 4 | 4 |
| Total, other adverse events | Phase II: Imatinib Mesylate 500 mg | 6 | 6 |
| Total, other adverse events | Phase 1: Imatinib Mesylate 600 mg | 2 | 2 |
| Total, other adverse events | Phase II: Imatinib Mesylate MTD 500 mg | 5 | 5 |
| Total, serious adverse events | Phase I: Imatinib Mesylate 400mg | 0 | 4 |
| Total, serious adverse events | Phase II: Imatinib Mesylate 500 mg | 0 | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Participants With Measurable Disease vs Participants With Non-Measurable Disease: Number of Participants With Complete Response |
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/NCT00506779
GET https://conductscience.org/api/trials/v1/NCT00506779/events?page=2