AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma (NCT00659360) | Clinical Trial Compass
CompletedPhase 2
AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma
United States, Canada17 participantsStarted 2008-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* ANC \>1,500/mcL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 8 weeks af…
What they're measuring
1
Disease Control Rate, Defined as the Number of Patients Who Achieved Complete Response, Partial Response or Stable Disease For a Period of More Than 4 Months.