TriangleNCT00787527 · OUTCOME
Phase II MTD of Vorinostat
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/three times daily
- Interval / dispersion
- Not reported
- Time frame
- 21 Days
What was measured
MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).
Groups in this outcome
Schedule B - Vorinostat Three Times Daily
Vorinostat administered orally 300 mg three times daily from days -2 to 3 (4500 mg over 5 days per cycle) of 21 day cycle. Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) Doxorubicin : 50 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle Cyclophosphamide : 750 mg/m\^2 by vein over 1 hour on Day 1 of 21 day cycle Vincristine : 1.4 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle
| Group | Source count |
|---|---|
| Schedule B - Vorinostat Three Times Daily | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Schedule B - Vorinostat Three Times Daily | 300 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 300
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).
- groups
- description
- Vorinostat administered orally 300 mg three times daily from days -2 to 3 (4500 mg over 5 days per cycle) of 21 day cycle. Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) Doxorubicin : 50 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle Prednisone : 100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle Cyclophosphamide : 750 mg/m\^2 by vein over 1 hour on Day 1 of 21 day cycle Vincristine : 1.4 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle
- id
- OG000
- title
- Schedule B - Vorinostat Three Times Daily
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 21 Days
- title
- Phase II MTD of Vorinostat
- type
- PRIMARY
- unit Of Measure
- mg/three times daily
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice