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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Pazopanib Hydrochloride in Patients With Refractory or Relapsed Metastatic Soft Tissue Sarcoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 and over	Other, Pharmaceutical / Industry	EORTC-62072 EORTC 62072, EU-20887, NCT00753688, PALETTE, GSK-VEG110727, EUDRACT-2008-001307-33

Trial Description

Purpose:

Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pazopanib is more effective than a placebo in treating patients with soft tissue sarcoma.

This randomized phase III trial is studying pazopanib to see how well it works compared with a placebo in treating patients with metastatic soft tissue sarcoma that has relapsed or not responded to treatment.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Progressive disease
• Measurable disease
• No brain metastases
• More than 6 months since amiodarone
• More than 6 months since angioplasty or stenting to the blood vessels around the heart
• More than 4 weeks since surgery
• More than 2 weeks since cyclosporine, tacrolimus, or sirolimus
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive pazopanib by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown.

Patients in group two will receive a placebo by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown.

After finishing treatment, patients will be evaluated every 2-3 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Winette Van der Graaf, MD, PhD, Principal investigator		Ph: 31-24-361-0353

Netherlands
	Nijmegen
	European Organization for Research and Treatment of Cancer
		Winette Van der Graaf, MD, PhD	Ph:  31-24-361-0353

Registry Information
Official Title		A randomized double blind phase III trial of Pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy.
Trial Start Date		2008-10-01
Registered in ClinicalTrials.gov		NCT00753688
Date Submitted to PDQ		2008-11-06
Information Last Verified		2008-12-23