AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma

Completed · Phase 2

Conditions studied: Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Liposarcoma, Adult Malignant Fibrous Histiocytoma, Adult Rhabdomyosarcoma, Dermatofibrosarcoma Protuberans, Endometrial Stromal Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Uterine Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage III Uterine Sarcoma, Stage IV Adult Soft Tissue Sarcoma, Stage IV Uterine Sarcoma, Uterine Carcinosarcoma, Uterine Leiomyosarcoma

In brief

This phase II trial is studying how well AZD0530 works in treating patients with recurrent locally advanced, or metastatic soft tissue sarcoma. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00659360

Run by

National Cancer Institute (NCI)

People needed

17

Starts

2008-02-01

Expected to finish

2012-11-01

Last updated by the study team

2018-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Leukocytes >= 3,000/mcL
• Histologically or cytologically confirmed soft tissue sarcoma including, but not limited to any of:
• Malignant fibrous histiocytoma
• Fibrosarcoma - non infantile
• Leiomyosarcoma - not uterine
• Liposarcoma
• Non-rhabdomyosarcoma soft tissue sarcoma
• Rhabdomyosarcoma, not otherwise specified
• Carcinosarcoma of the uterus
• Dermatofibrosarcoma
• Endometrial stromal sarcoma
• Leiomyosarcoma - uterus
• Recurrent or locally advanced or metastatic disease
• No more than two prior lines of chemotherapy for metastatic disease (not including adjuvant chemotherapy)
• Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan
• Target measurable lesion must not have been in previous radiation portal, unless progression of this lesion after radiotherapy has been documented
• ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
• Life expectancy > 12 weeks
• Recovered from all prior therapy
• Platelet count >= 100,000/mcL
• Hemoglobin > 9 g/dL
• Total bilirubin =< 1.25 times upper limit of normal (ULN)
• AST and ALT =< 3 times ULN
• Creatinine =< 1.5 times ULN OR creatinine clearance >= 50 mL/min
• Urine protein:creatinine ratio =< 1.0 OR 24-hour urine protein < 1,000 mg

You may not qualify if…

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
• No intercurrent cardiac dysfunction including, but not limited to, any of the following:
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• No history of ischemic heart disease, including myocardial infarction
• No uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
• More than 4 weeks since prior radiotherapy
• More than 7 days since prior and no concurrent prohibited CYP3A4-active agents or substances
• No other concurrent investigational agents or commercial agents or therapies
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No known brain metastases

Where it is running

• Fox Chase Cancer Center — Rockledge, Pennsylvania, United States
• Cross Cancer Institute — Edmonton, Alberta, Canada
• University Health Network-Princess Margaret Hospital — Toronto, Ontario, Canada
• Montreal General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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