Trial Outcomes & Findings for Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI) (NCT NCT00410488)
NCT ID: NCT00410488
Last Updated: 2013-03-22
Results Overview
Number of participants with dose of palonosetron who experienced response (no emesis) during acute and delayed time period of the study (10 days) divided by number of participants. Complete response defined as no emesis and no rescue medicines in 10 days from the start of chemotherapy in the first chemotherapy cycle.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
10 days
Results posted on
2013-03-22
Participant Flow
Recruitment period: November 27, 2006 to March 22, 2011. All recruitment done in medical clinic at UT MD Anderson Cancer Center.
One participant of the 51 participants recruited withdrew from the trial before assignment to groups and therefore was excluded.
Participant milestones
| Measure |
Palonosetron - 1 Dose
Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology).
|
Palonosetron - 3 Doses
Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology).
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
34
|
|
Overall Study
COMPLETED
|
16
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)
Baseline characteristics by cohort
| Measure |
Palonosetron - 1 Dose
n=16 Participants
Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology).
|
Palonosetron - 3 Doses
n=34 Participants
Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology).
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
47 years
n=99 Participants
|
52 years
n=107 Participants
|
50 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
34 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 10 daysNumber of participants with dose of palonosetron who experienced response (no emesis) during acute and delayed time period of the study (10 days) divided by number of participants. Complete response defined as no emesis and no rescue medicines in 10 days from the start of chemotherapy in the first chemotherapy cycle.
Outcome measures
| Measure |
Palonosetron - 1 Dose
n=16 Participants
Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology).
|
Palonosetron - 3 Doses
n=34 Participants
Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology).
|
|---|---|---|
|
Palonosetron Response Rate in the 10 Day Study Cycle
|
31.25 percentage of participants
Interval 12.1 to 58.5
|
50 percentage of participants
Interval 32.75 to 67.25
|
Adverse Events
Palonosetron
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Palonosetron
n=50 participants at risk
Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0) and Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).
Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology).
|
|---|---|
|
General disorders
Headache
|
18.0%
9/50 • 3 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/50 • 3 years and 7 months
|
|
Cardiac disorders
Palpitation
|
2.0%
1/50 • 3 years and 7 months
|
|
General disorders
Fatigue
|
4.0%
2/50 • 3 years and 7 months
|
|
Gastrointestinal disorders
Constiptation
|
28.0%
14/50 • 3 years and 7 months
|
|
Skin and subcutaneous tissue disorders
Paresthesia
|
2.0%
1/50 • 3 years and 7 months
|
|
Gastrointestinal disorders
Gastrointestinal Others
|
4.0%
2/50 • 3 years and 7 months
|
|
General disorders
Weakness
|
2.0%
1/50 • 3 years and 7 months
|
|
Skin and subcutaneous tissue disorders
Skin Changes
|
2.0%
1/50 • 3 years and 7 months
|
|
Gastrointestinal disorders
Indigestion
|
2.0%
1/50 • 3 years and 7 months
|
|
General disorders
Hiccups
|
2.0%
1/50 • 3 years and 7 months
|
|
General disorders
Sweat
|
2.0%
1/50 • 3 years and 7 months
|
|
Gastrointestinal disorders
Anorexia
|
4.0%
2/50 • 3 years and 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place