Trial Outcomes & Findings for Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer (NCT NCT00114218)
NCT ID: NCT00114218
Last Updated: 2019-01-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
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.
Results posted on
2019-01-08
Participant Flow
This trial was opened to patient entry on March 7, 2005 and was closed to accrual on October 29, 2007
Participant milestones
| Measure |
Treatment (Gemcitabine Hydrochloride, Docetaxel)
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
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Gemcitabine Hydrochloride, Docetaxel)
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
|
|---|---|
|
Overall Study
Wrong Cell Type
|
2
|
|
Overall Study
Wrong Primary
|
1
|
|
Overall Study
Never Treated
|
1
|
Baseline Characteristics
Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Gemcitabine Hydrochloride, Docetaxel)
n=24 Participants
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
|
|---|---|
|
Age, Customized
<50 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
5 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
12 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
>79 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: Eligible and Treated patients
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.
Outcome measures
| Measure |
Treatment (Gemcitabine Hydrochloride, Docetaxel)
n=24 Participants
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
|
|---|---|
|
Percentage of Patients With Objective Tumor Response Rate (Either Complete Response (CR) or Partial Response (PR) Using RECIST Version 1.0
|
8 Percentage of participants
Interval 1.0 to 27.0
|
PRIMARY outcome
Timeframe: 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-upPopulation: Eligible and Treated patients
Count of participants with Toxicities maximum grade greater than or equal to grade 3
Outcome measures
| Measure |
Treatment (Gemcitabine Hydrochloride, Docetaxel)
n=24 Participants
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
|
|---|---|
|
Incidence of Adverse Effects That Are Grade 3 or Greater as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
|
18 Participants
|
Adverse Events
Treatment (Gemcitabine Hydrochloride, Docetaxel)
Serious events: 11 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Gemcitabine Hydrochloride, Docetaxel)
n=24 participants at risk
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
|
|---|---|
|
General disorders
Pain: Extremity-Limb
|
4.2%
1/24 • 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
|
|
General disorders
Pain -Back
|
4.2%
1/24 • 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
|
|
Gastrointestinal disorders
Constipation
|
8.3%
2/24 • 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
|
|
Investigations
Bilirubin
|
4.2%
1/24 • 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
|
|
Investigations
Alkaline Phosphatase
|
4.2%
1/24 • 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
|
|
General disorders
Death No CTCAE Term-Sudden Death
|
8.3%
2/24 • 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
|
|
General disorders
Fatigue
|
8.3%
2/24 • 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
|
|
General disorders
Death No CTCAE Term -Disease Progression NOS
|
8.3%
2/24 • 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
|
|
Hepatobiliary disorders
Hemorrhage, GI - Liver
|
4.2%
1/24 • 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
|
|
General disorders
Abdominal Pain NOS
|
4.2%
1/24 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
1/24 • 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
|
|
General disorders
Edema: Limb
|
4.2%
1/24 • 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
|
|
Blood and lymphatic system disorders
Neutrophils
|
4.2%
1/24 • 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
|
|
General disorders
Muscle Weakness - Whole body/Generalized
|
4.2%
1/24 • 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
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.2%
1/24 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.2%
1/24 • 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
|
|
Gastrointestinal disorders
Obstruction, GI-Small Bowel
|
4.2%
1/24 • 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
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
1/24 • 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
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
4.2%
1/24 • 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
|
|
General disorders
Pain: Kidney
|
4.2%
1/24 • 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
|
|
Renal and urinary disorders
Obstrusction, GU -Ureter
|
4.2%
1/24 • 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
|
Other adverse events
| Measure |
Treatment (Gemcitabine Hydrochloride, Docetaxel)
n=24 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
75.0%
18/24 • 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
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
62.5%
15/24 • 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
|
|
Blood and lymphatic system disorders
Neutropenia
|
75.0%
18/24 • 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
|
|
Blood and lymphatic system disorders
Anemia
|
83.3%
20/24 • 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
|
|
Gastrointestinal disorders
Nausea
|
45.8%
11/24 • 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
|
|
Gastrointestinal disorders
Other Gastrointestinal
|
58.3%
14/24 • 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
|
|
Renal and urinary disorders
Genitourinary
|
8.3%
2/24 • 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
|
|
Nervous system disorders
Neurotoxicity
|
25.0%
6/24 • 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
|
|
General disorders
Pain
|
16.7%
4/24 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
12.5%
3/24 • 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
|
|
Cardiac disorders
Cardiovascular
|
8.3%
2/24 • 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
|
|
General disorders
Fatigue
|
37.5%
9/24 • 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
|
|
Metabolism and nutrition disorders
Metabolic
|
37.5%
9/24 • 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
|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
16.7%
4/24 • 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
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
41.7%
10/24 • 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
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
4.2%
1/24 • 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
|
|
Investigations
SGOT
|
12.5%
3/24 • 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
|
|
Investigations
Alkaline Phosphatase
|
12.5%
3/24 • 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
|
|
Blood and lymphatic system disorders
Lymphatics
|
16.7%
4/24 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60