NCT00114218 · STUDY IN CONTEXT

Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Eligible and Treated patients

→

primary · POSTED

Count of participants with Toxicities maximum grade greater than or equal to grade 3

Eligible and Treated patients

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-uterine-sarcoma-recurrent-8e0b2edc
nct id: NCT00114218
trial label: Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 2
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00114218
outcome key
om-0000
source section id
NCT00114218-om-0000
source outcome index
0
endpoint
Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0
endpoint definition
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.
time origin
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.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and Treated patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00114218
outcome key
om-0001
source section id
NCT00114218-om-0001
source outcome index
1
endpoint
Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
endpoint definition
Count of participants with Toxicities maximum grade greater than or equal to grade 3
time origin
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
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and Treated patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00114218
outcome key
om-0000
arm key
OG000
arm label
Treatment (Gemcitabine Hydrochloride, Docetaxel)
regimen
Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Gemcitabine Hydrochloride: Given IV Docetaxel: Given IV
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00114218-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00114218
outcome key
om-0001
arm key
OG000
arm label
Treatment (Gemcitabine Hydrochloride, Docetaxel)
regimen
Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Gemcitabine Hydrochloride: Given IV Docetaxel: Given IV
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00114218-om-0001#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-uterine-sarcoma-recurrent-8e0b2edc
nct id
NCT00114218
harm key
EG000
source section id
NCT00114218-ae
event group key
EG000
event group label
Treatment (Gemcitabine Hydrochloride, Docetaxel)
serious affected
11
serious at risk
24
other affected
22
other at risk
24
frequency threshold
0
collection period
AEs were assessed every 28 days (1cycle) while on study treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice