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

This study has been completed.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00410488
First received: December 11, 2006
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

The goal of this clinical research study is to compare 2 treatment schedules of Aloxi (palonosetron) in patients with sarcoma who are receiving chemotherapy with adriamycin and ifosfamide. The safety of the drug and schedules will be studied. The effect of palonosetron on patients' quality of life (QOL) will also be studied.


Condition Intervention
Sarcoma
Nausea
Vomiting
Drug: Palonosetron - Single Dose
Drug: Palonosetron - Triple Dose
Drug: Adriamycin
Drug: Ifosfamide chemotherapy (AI)
Drug: Zinecard
Drug: Mesna
Drug: Vincristine
Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Dose/Schedule Finding Study of Palonosetron in Sarcoma Patients Receiving Multi-Day Chemotherapy With Adriamycin and Ifosfamide (AI)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Palonosetron Response Rate in the 10 Day Study Cycle [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 51
Study Start Date: December 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).

Drug: Palonosetron - Single Dose
0.25 mg by vein for 1 dose (day 0).
Other Name: Aloxi
Drug: Adriamycin
75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0.
Other Names:
  • Doxorubicin
  • Doxorubicin Hydrochloride
  • Adriamycin PFS
  • Adrimaycin RDF
  • Rubex
Drug: Ifosfamide chemotherapy (AI)
Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2). Cycle is 3 weeks, up to 6 cycles.
Other Name: Ifex
Drug: Zinecard
750 mg/m2 as an IV bolus.
Other Name: Dexrazoxane
Drug: Mesna
500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hour for days 0, 1, 2, and 3 (infusion completing on day 4).
Other Name: mesnex
Drug: Vincristine

2 mg IV by rapid administration on day 0 (for patients with small cell histology).

For patients with certain types of sarcoma, vincristine will be given through the catheter by rapid infusion on Day 0 only.

Drug: Dexamethasone
IV piggyback (IVPB) daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy.
Other Names:
  • Decadron
  • Dexamethasone acetate
Active Comparator: 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).

Drug: Palonosetron - Triple Dose
0.25 mg by vein for 3 doses (days 0, 2, 4).
Other Name: Aloxi
Drug: Adriamycin
75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0.
Other Names:
  • Doxorubicin
  • Doxorubicin Hydrochloride
  • Adriamycin PFS
  • Adrimaycin RDF
  • Rubex
Drug: Ifosfamide chemotherapy (AI)
Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2). Cycle is 3 weeks, up to 6 cycles.
Other Name: Ifex
Drug: Zinecard
750 mg/m2 as an IV bolus.
Other Name: Dexrazoxane
Drug: Mesna
500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hour for days 0, 1, 2, and 3 (infusion completing on day 4).
Other Name: mesnex
Drug: Vincristine

2 mg IV by rapid administration on day 0 (for patients with small cell histology).

For patients with certain types of sarcoma, vincristine will be given through the catheter by rapid infusion on Day 0 only.

Drug: Dexamethasone
IV piggyback (IVPB) daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy.
Other Names:
  • Decadron
  • Dexamethasone acetate

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with AI is indicated.
  • Must be between the ages of 18 and 65 years of age.
  • Patients with childbearing potential (defined as not post menopausal for 12 months or no previous surgical sterilization) must use adequate birth control.
  • Adequate hematologic (Absolute neutrophil count (ANC)>/= 1500/mm^3, >/= hemoglobin (Hgb, Hb) 10gm/dL, platelet count >/= 150,000/mm^3), renal (serum creatinine </= 1.5 mg/dL), hepatic (serum bilirubin count </= 1.5 * normal and Serum glutamic pyruvic transaminase (SGPT) <3 * normal) functions.
  • Karnofsky Performance Status >/= 80.
  • Signed informed consent form.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Patients with comorbid condition which renders patients at high risk of treatment complication.
  • Patients with symptomatic or untreated metastatic disease to CNS.
  • Patients with significant cardiac disease (New York Heart Association (NYHA) Class III or IV), arrhythmia, or recent history of Myocardial infarction (MI) or ischemia.
  • Patients with known hypersensitivity to 5-HT3 antagonists.
  • Any vomiting or >/= grade 2 nausea in the 24 hours preceding chemotherapy.
  • Ongoing vomiting from any organic etiology.
  • Radiotherapy within 2 weeks of study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410488

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eisai Inc.
Investigators
Principal Investigator: Saroj Vadhan-Raj, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00410488     History of Changes
Other Study ID Numbers: 2005-0664
Study First Received: December 11, 2006
Results First Received: June 28, 2012
Last Updated: February 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Sarcoma
Palonosetron
Aloxi
Nausea
Vomiting

Additional relevant MeSH terms:
Sarcoma
Vomiting
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Signs and Symptoms
Signs and Symptoms, Digestive
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Dexrazoxane
Doxorubicin
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Palonosetron
Razoxane
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Autonomic Agents
Cardiotonic Agents

ClinicalTrials.gov processed this record on October 23, 2014