Trial Outcomes & Findings for Gemcitabine Pharmacokinetics After Preoperative Chemoradiation Therapy (NCT NCT01938716)
NCT ID: NCT01938716
Last Updated: 2020-11-05
Results Overview
The quantification of serum, PBMC, and cancer tissue levels of gemcitabine from frozen samples will be assessed using standardized techniques in high performance liquid chromatography-mass spectometry (HPLC/MS).
TERMINATED
NA
12 participants
through study completion, up to 2 years and 6 months
2020-11-05
Participant Flow
Recruitment period: March 2012 to February 2015. All recruitment done at The University of Texas, MD Anderson Cancer Center.
Participant milestones
| Measure |
Intraoperative Gemcitabine Administration
Gemcitabine administered intravenously at dose of 500 - 750 mg/m2 at a fixed dose rate of 10mg/m2/min, 50-75 minutes prior to complete gross tumor removal.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Intraoperative Gemcitabine Administration
Gemcitabine administered intravenously at dose of 500 - 750 mg/m2 at a fixed dose rate of 10mg/m2/min, 50-75 minutes prior to complete gross tumor removal.
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Gemcitabine Pharmacokinetics After Preoperative Chemoradiation Therapy
Baseline characteristics by cohort
| Measure |
Intraoperative Gemcitabine Administration
n=12 Participants
Gemcitabine administered intravenously at dose of 500 - 750 mg/m2 at a fixed dose rate of 10mg/m2/min, 50-75 minutes prior to complete gross tumor removal.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through study completion, up to 2 years and 6 monthsPopulation: Samples inadequate for testing to meet objective; early termination of protocol due to low accrual.
The quantification of serum, PBMC, and cancer tissue levels of gemcitabine from frozen samples will be assessed using standardized techniques in high performance liquid chromatography-mass spectometry (HPLC/MS).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through study completion, up to 2 years and 6 monthsPopulation: Samples inadequate for testing to meet objective; early termination of protocol due to low accrual.
Gemcitabine incorporation in DNA will be quantified by a proprietary LC/MS/MS method developed by Eli Lilly and performed by Advion BioServices. DNA extracted from the tissue samples to be sent to Advion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through study completion, up to 2 years and 6 monthsPopulation: Samples inadequate for testing to meet objective; early termination of protocol due to low accrual
The mRNA level is measured using real time PCR and protein expressed by IHC, Gene expression level will be correlated to the gemcitabine measurements. Additionally measure markers of proliferation and apoptosis by p21and ki67 IHC and fluorescent TUNEL analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through study completion, up to 2 years and 6 monthsPopulation: Samples inadequate for testing to meet objective; early termination of protocol due to low accrual.
The mRNA and protein expression of SHH, Gli, and SMO will be measured by RT-PCR and IHC method, respectively.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through study completion, up to 2 years and 6 monthsPopulation: Samples inadequate for testing to meet objective; early termination of protocol due to low accrual.
Measure markers of of proliferation and apoptosis by p21 and ki67 IHC and fluorescent TUNEL analysis.
Outcome measures
Outcome data not reported
Adverse Events
Intraoperative Gemcitabine Administration
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intraoperative Gemcitabine Administration
n=8 participants at risk
Gemcitabine administered intravenously at dose of 500 - 750 mg/m2 at a fixed dose rate of 10mg/m2/min, 50-75 minutes prior to complete gross tumor removal.
|
|---|---|
|
Investigations
White blood cell decreased
|
62.5%
5/8 • Adverse event data collected from intraoperative gemcitabine infusion, during post-surgery hospitalization and followed for 30 day post surgery
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8 • Adverse event data collected from intraoperative gemcitabine infusion, during post-surgery hospitalization and followed for 30 day post surgery
|
|
Investigations
Neutrophilcount decreased
|
37.5%
3/8 • Adverse event data collected from intraoperative gemcitabine infusion, during post-surgery hospitalization and followed for 30 day post surgery
|
|
Investigations
Platelet count decreased
|
50.0%
4/8 • Adverse event data collected from intraoperative gemcitabine infusion, during post-surgery hospitalization and followed for 30 day post surgery
|
Additional Information
Dr. Gauri R Varadhachary,Professor, GI Medical Oncology
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place