Trial Outcomes & Findings for Safety & Efficacy Study of Gemcitabine...With High Dose IV Vit. C (HDIVC) (NCT NCT01654861)
NCT ID: NCT01654861
Last Updated: 2018-07-26
Results Overview
Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued. Subjects experiencing Grade 4 neutropenia, Grade ≥3 thrombocytopenia, or Grade 2 peripheral neuropathy who do not recover will have treatment protocol discontinued.
TERMINATED
PHASE1
3 participants
Weekly for up to 6 months.
2018-07-26
Participant Flow
Participant milestones
| Measure |
HDIVC
Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).
Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose \>90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.
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|---|---|
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Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety & Efficacy Study of Gemcitabine...With High Dose IV Vit. C (HDIVC)
Baseline characteristics by cohort
| Measure |
HDIVC
n=3 Participants
Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).
Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose \>90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weekly for up to 6 months.Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued. Subjects experiencing Grade 4 neutropenia, Grade ≥3 thrombocytopenia, or Grade 2 peripheral neuropathy who do not recover will have treatment protocol discontinued.
Outcome measures
| Measure |
HDIVC
n=3 Participants
Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).
Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose \>90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.
|
|---|---|
|
Adverse Events as a Measure of Safety and Tolerability
|
0 participants
|
SECONDARY outcome
Timeframe: Every 2 months for up to 6 months.Population: Data were not analyzed as the study was prematurely closed.
CT and PET scans will be performed at baseline and then every two months. Target and Non-Target Lesions will be identified and recorded at baseline. When subsequent scans are performed, anti-tumor responses will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST).
Outcome measures
Outcome data not reported
Adverse Events
HDIVC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place