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

This study is currently recruiting participants.

Verified by M.D. Anderson Cancer Center, June 2009

First Received: December 11, 2006 Last Updated: June 4, 2009 History of Changes

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

Purpose

Objectives:

To identify a schedule of palonosetron that is appropriate for the prevention of acute and delayed nausea/emesis in patients receiving multi-day chemotherapy.

Condition	Intervention
Sarcoma Nausea Vomiting	Drug: Palonosetron

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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 Myocet RS 25233-197 Palonosetron Hydrochloride Ifosfamide

U.S. FDA Resources

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

Primary Outcome Measures:

Comparison of 2 treatment schedules of Aloxi (palonosetron) in patients with sarcoma receiving chemotherapy with adriamycin and ifosfamide. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Effect of palonosetron on patients' quality of life (QOL) [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	December 2006
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Palonosetron X 1 Dose: Active Comparator	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).
Palonosetron X 3 Doses: Experimental	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).

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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

Contacts

Contact: Pamela Walker, RN

713-745-2767

Locations

United States, Texas
The University of Texas M.D.Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Saroj Vadhan-Raj, MD

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 This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Saroj Vadhan-Raj, MD/Professor )
Study ID Numbers:	2005-0664
Study First Received:	December 11, 2006
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00410488 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Sarcoma
Palonosetron
Aloxi
Nausea
Vomiting

Additional relevant MeSH terms:

Neurotransmitter Agents
Vomiting
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Signs and Symptoms

Neoplasms, Connective and Soft Tissue
Serotonin Antagonists
Neoplasms
Ifosfamide
Palonosetron
Serotonin Agents
Therapeutic Uses
Sarcoma
Nausea
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on November 09, 2009