Trial Outcomes & Findings for Oxaliplatin Microdosing Assay in Predicting Exposure and Sensitivity to Oxaliplatin-Based Chemotherapy (NCT NCT02569723)
NCT ID: NCT02569723
Last Updated: 2021-03-30
Results Overview
Correlate area under curve from phase 0 microdosing with area under curve for therapeutic dose of oxaliplatin
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
0-5 minutes predose, 5, 15, and 30 minutes, and at 1, 2, 4, 8, and 24 hours after carbon C 14 oxaliplatin microdose
Results posted on
2021-03-30
Participant Flow
Participant milestones
| Measure |
Carbon C 14 Oxaliplatin and Oxaliplatin
Patients receive carbon C 14 oxaliplatin microdose IV over 120 minutes. Beginning not more than 4 weeks after the initial carbon C 14 oxaliplatin microdose administration, patients receive FOLFOX6 comprised of leucovorin calcium IV, fluorouracil IV over 2 hours (over 46-48 hours via ambulatory infusion pump on days 1 and 2), and oxaliplatin (contain carbon C 14 microdose course I only) IV over 2 hours on day 1.
Carbon C 14 Oxaliplatin: Intravenous infusion
Oxaliplatin: Intravenous infusion
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxaliplatin Microdosing Assay in Predicting Exposure and Sensitivity to Oxaliplatin-Based Chemotherapy
Baseline characteristics by cohort
| Measure |
Carbon C 14 Oxaliplatin and Oxaliplatin
n=6 Participants
Patients receive carbon C 14 oxaliplatin microdose IV over 120 minutes. Beginning not more than 4 weeks after the initial carbon C 14 oxaliplatin microdose administration, patients receive FOLFOX6 comprised of leucovorin calcium IV, fluorouracil IV over 2 hours (over 46-48 hours via ambulatory infusion pump on days 1 and 2), and oxaliplatin (contain carbon C 14 microdose course I only) IV over 2 hours on day 1.
Carbon C 14 Oxaliplatin: Intravenous infusion
Oxaliplatin: Intravenous infusion
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-5 minutes predose, 5, 15, and 30 minutes, and at 1, 2, 4, 8, and 24 hours after carbon C 14 oxaliplatin microdoseCorrelate area under curve from phase 0 microdosing with area under curve for therapeutic dose of oxaliplatin
Outcome measures
| Measure |
Carbon C 14 Oxaliplatin and Oxaliplatin
n=6 Participants
Patients receive carbon C 14 oxaliplatin microdose IV over 120 minutes. Beginning not more than 4 weeks after the initial carbon C 14 oxaliplatin microdose administration, patients receive FOLFOX6 comprised of leucovorin calcium IV, fluorouracil IV over 2 hours (over 46-48 hours via ambulatory infusion pump on days 1 and 2), and oxaliplatin (contain carbon C 14 microdose course I only) IV over 2 hours on day 1.
Carbon C 14 Oxaliplatin: Intravenous infusion
Oxaliplatin: Intravenous infusion
|
|---|---|
|
Feasibility of 14C Oxaliplatin Microdose as a Clinical Assay to Predict Oxaliplatin Exposure
|
0.63 R squared
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Tumor measurements were not collected to assess this outcome measure.
Will characterize the repair of DNA adducts in PBMC, using descriptive statistics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 monthsAssess toxicity to both microdoses of carbon C 14 oxaliplatin. Toxicities potentially related to carbon C 14 oxaliplatin will be assessed from initiation of the study to at least 14 days after the administration of the FOLFOX-integrated microdose or until full recover of toxicity (whichever is longer). Safety will be assessed through summaries of adverse events and laboratory evaluations.
Outcome measures
| Measure |
Carbon C 14 Oxaliplatin and Oxaliplatin
n=6 Participants
Patients receive carbon C 14 oxaliplatin microdose IV over 120 minutes. Beginning not more than 4 weeks after the initial carbon C 14 oxaliplatin microdose administration, patients receive FOLFOX6 comprised of leucovorin calcium IV, fluorouracil IV over 2 hours (over 46-48 hours via ambulatory infusion pump on days 1 and 2), and oxaliplatin (contain carbon C 14 microdose course I only) IV over 2 hours on day 1.
Carbon C 14 Oxaliplatin: Intravenous infusion
Oxaliplatin: Intravenous infusion
|
|---|---|
|
Number of Participants With Adverse Events According to CTCAE Version 4
Anorexia
|
1 Participants
|
|
Number of Participants With Adverse Events According to CTCAE Version 4
Arthralgia
|
1 Participants
|
|
Number of Participants With Adverse Events According to CTCAE Version 4
Dehydration
|
1 Participants
|
|
Number of Participants With Adverse Events According to CTCAE Version 4
Diarrhea
|
2 Participants
|
|
Number of Participants With Adverse Events According to CTCAE Version 4
Endocrine disorders - Other - Cold sensitivity
|
1 Participants
|
|
Number of Participants With Adverse Events According to CTCAE Version 4
Fatigue
|
3 Participants
|
|
Number of Participants With Adverse Events According to CTCAE Version 4
Hyperkalemia
|
1 Participants
|
|
Number of Participants With Adverse Events According to CTCAE Version 4
Lymphocyte count decreased
|
2 Participants
|
|
Number of Participants With Adverse Events According to CTCAE Version 4
Nausea
|
3 Participants
|
|
Number of Participants With Adverse Events According to CTCAE Version 4
Neutrophil count decreased
|
1 Participants
|
|
Number of Participants With Adverse Events According to CTCAE Version 4
Pain in extremity
|
1 Participants
|
|
Number of Participants With Adverse Events According to CTCAE Version 4
Peripheral sensory neuropathy
|
1 Participants
|
|
Number of Participants With Adverse Events According to CTCAE Version 4
Vomiting
|
1 Participants
|
|
Number of Participants With Adverse Events According to CTCAE Version 4
White blood cell decreased
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Tumor measurements were not collected to assess this outcome measure.
Response was determined according to RECIST criteria as either partial response (PR) or one almost complete response (CR) or progressive disease (PD).
Outcome measures
Outcome data not reported
Adverse Events
Carbon C 14 Oxaliplatin and Oxaliplatin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 6 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Carbon C 14 Oxaliplatin and Oxaliplatin
n=6 participants at risk
Patients receive carbon C 14 oxaliplatin microdose IV over 120 minutes. Beginning not more than 4 weeks after the initial carbon C 14 oxaliplatin microdose administration, patients receive FOLFOX6 comprised of leucovorin calcium IV, fluorouracil IV over 2 hours (over 46-48 hours via ambulatory infusion pump on days 1 and 2), and oxaliplatin (contain carbon C 14 microdose course I only) IV over 2 hours on day 1.
Carbon C 14 Oxaliplatin: Intravenous infusion
Oxaliplatin: Intravenous infusion
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
|
Endocrine disorders
Endocrine disorders - Other - Cold sensitivity
|
16.7%
1/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
|
General disorders
Fatigue
|
50.0%
3/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
|
Investigations
Lymphocyte count decreased
|
33.3%
2/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • Up to 2 years
Incidence of Adverse Events According to the Common Terminology Criteria for Adverse Events Version 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place