Recurrent Adult Soft Tissue Sarcoma Clinical Trial
Official title:
A Phase 2 Study of AZD0530 in Recurrent or Metastatic Soft Tissue Sarcoma
Verified date | May 2018 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | November 2012 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 after completion of study therapy - No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530 - No QTc prolongation (defined as a QTc interval >= to 460 msecs) or other significant ECG abnormalities - No poorly controlled hypertension (i.e., systolic blood pressure (BP) >= 140 mm Hg, or diastolic BP >= 90 mm Hg) - No condition that impairs a patient's ability to swallow AZD0530 tablets, including any of the following: - Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation - Prior surgical procedures affecting absorption - Active peptic ulcer disease Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | Montreal General Hospital | Montreal | Quebec |
Canada | University Health Network-Princess Margaret Hospital | Toronto | Ontario |
United States | Fox Chase Cancer Center | Rockledge | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Changes in only the largest diameter (unidimensional measurement) of the tumor lesions; where CR is disappearance of all target lesions, PR is at least 30% decrease in the sum of longest diameter, PD is at least 20% increase in the sum of longest diameter recorded since the treatment started and SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD | Up to 5 years | |
Secondary | Objective Response Rate | Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions | Up to 5 years | |
Secondary | Overall Survival | Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates. | Up to 5 years | |
Secondary | Stable Disease Rate | Achieved stable disease as their best response | Up to 5 years | |
Secondary | Duration of Response | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Tumor Response "of more than 4 months" was counted toward the Disease Control Rate. |
Up to 5 years | |
Secondary | Time to Disease Progression | The Kaplan-Meier method will be used to estimate time to progression estimates. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
Up to 5 years |
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