Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI) - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Eisai Inc.
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00410488

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

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:

MedlinePlus related topics: Cancer Nausea and Vomiting Soft Tissue Sarcoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride RS 25233-197 Palonosetron Hydrochloride Ifosfamide

U.S. FDA Resources

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

Primary Outcome Measures:

Dose of palonosetron resulting in the greatest proportion of patients experiencing response (no emesis) during acute and delayed time period of the study (10 days). [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

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 X 1 Dose	Drug: Palonosetron Arm 1: 0.25 mg by vein x 1 dose (day 0). Arm 2: 0.25 mg by vein x 3 doses (days 0, 2, 4). Other Name: Aloxi
Experimental: Palonosetron X 3 Doses	Drug: Palonosetron Arm 1: 0.25 mg by vein x 1 dose (day 0). Arm 2: 0.25 mg by vein x 3 doses (days 0, 2, 4). Other Name: Aloxi

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 (ANC >/= 1500/mm^3, >/= Hgb 10gm/dL, platelet count >/= 150,000/mm^3), renal (serum creatinine </= 1.5 mg/dL), hepatic (serum bilirubin count </= 1.5 x normal and SGPT <3x 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 (NYHA Class III or IV), arrhythmia, or recent history of 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

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:

UT MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

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
Last Updated:	December 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Sarcoma
Palonosetron
Aloxi
Nausea
Vomiting

Additional relevant MeSH terms:

Nausea
Vomiting
Sarcoma
Signs and Symptoms, Digestive
Signs and Symptoms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Ifosfamide
Palonosetron

Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012