MDACC Study Summary 2005-0664 (Archived)

Study Summary
No. 2005-0664:.......Sarcoma......Saroj Vadhan-Raj......Cytokines and Supportive Care

Study Summary Title



Study Summary Number:	2005-0664

Study Title:	Dose/Schedule finding study of Palonosetron in Sarcoma patients receiving multi-day chemotherapy with adriamycin and ifosfamide (AI)

Physician

New Patient Referral



Name:	Saroj Vadhan-Raj	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Cytokines and Supportive Care	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7966 Contact us about clinical trials

General Information



Disease Group:	Sarcoma	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Prior to each cycle (approximately every three weeks).

Treatment Agents:	Doxorubicin Ifosfamide Neulasta Palonosetron	Home Care:	Routine labs, management of myelosuppression (antibiotics, transfusions) and supportive care.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Approximately 5 to 6 days each cycle, if hospitalization is required.


Description/ Intervention:	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.

Study Objectives / Outcomes

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

Study Status Information



Study Activation / Registration Date:	11/27/2006

IRB Review and Approval Date:	12/21/2005

Study Type:	Phase I

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with AI is indicated.

2) Must be between the ages of 18 and 65 years of age.

3) Patients with childbearing potential (defined as not post menopausal for 12 months or no previous surgical sterilization) must use adequate birth control.

4) 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.

5) Karnofsky Performance Status >/= 80.

6) Signed informed consent form.

Exclusion Criteria:

1) Pregnant or lactating women.

2) Patients with comorbid condition which renders patients at high risk of treatment complication.

3) Patients with symptomatic or untreated metastatic disease to CNS.

4) Patients with significant cardiac disease (NYHA Class III or IV), arrhythmia, or recent history of MI or ischemia.

5) Patients with known hypersensitivity to 5-HT3 antagonists.

6) Any vomiting or >/= grade 2 nausea in the 24 hours preceding chemotherapy.

7) Ongoing vomiting from any organic etiology.

8) Radiotherapy within 2 weeks of study entry.

Links

Registration Number: NCT00410488
Study Information on Clinical Trials Registry (clinicaltrials.gov)