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Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)

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ClinicalTrials.gov Identifier: NCT00410488
Recruitment Status : Completed
First Posted : December 13, 2006
Results First Posted : March 22, 2013
Last Update Posted : March 22, 2013
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Sarcoma
Nausea
Vomiting
Interventions Drug: Palonosetron - Single Dose
Drug: Palonosetron - Triple Dose
Drug: Adriamycin
Drug: Ifosfamide chemotherapy (AI)
Drug: Zinecard
Drug: Mesna
Drug: Vincristine
Drug: Dexamethasone
Enrollment 51
Recruitment Details Recruitment period: November 27, 2006 to March 22, 2011. All recruitment done in medical clinic at UT MD Anderson Cancer Center.
Pre-assignment Details One participant of the 51 participants recruited withdrew from the trial before assignment to groups and therefore was excluded.
Arm/Group Title Palonosetron - 1 Dose Palonosetron - 3 Doses
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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).

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).

Period Title: Overall Study
Started 16 34
Completed 16 34
Not Completed 0 0
Arm/Group Title Palonosetron - 1 Dose Palonosetron - 3 Doses Total
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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).

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 of all reporting groups
Overall Number of Baseline Participants 16 34 50
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants 34 participants 50 participants
47
(21 to 64)
52
(22 to 66)
50
(21 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 34 participants 50 participants
Female
6
  37.5%
15
  44.1%
21
  42.0%
Male
10
  62.5%
19
  55.9%
29
  58.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 34 participants 50 participants
16 34 50
1.Primary Outcome
Title Palonosetron Response Rate in the 10 Day Study Cycle
Hide Description 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.
Time Frame 10 days
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palonosetron - 1 Dose Palonosetron - 3 Doses
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 16 34
Measure Type: Number
Unit of Measure: percentage of participants
31.25 50
Time Frame 3 years and 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Palonosetron
Hide Arm/Group Description

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).

All-Cause Mortality
Palonosetron
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Palonosetron
Affected / at Risk (%)
Total   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Palonosetron
Affected / at Risk (%)
Total   37/50 (74.00%) 
Cardiac disorders   
Palpitation  1  1/50 (2.00%) 
Gastrointestinal disorders   
Constiptation  1  14/50 (28.00%) 
Gastrointestinal Others  1 [1]  2/50 (4.00%) 
Indigestion  1  1/50 (2.00%) 
Anorexia  1  2/50 (4.00%) 
General disorders   
Headache  1  9/50 (18.00%) 
Fatigue  1  2/50 (4.00%) 
Weakness  1  1/50 (2.00%) 
Hiccups  1  1/50 (2.00%) 
Sweat  1  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/50 (2.00%) 
Skin and subcutaneous tissue disorders   
Paresthesia  1  1/50 (2.00%) 
Skin Changes  1  1/50 (2.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Altered Taste; Reflux
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Saroj Vadhan-Raj, MD / Professor
Organization: UT MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00410488     History of Changes
Other Study ID Numbers: 2005-0664
First Submitted: December 11, 2006
First Posted: December 13, 2006
Results First Submitted: June 28, 2012
Results First Posted: March 22, 2013
Last Update Posted: March 22, 2013