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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Stage III Adult Soft Tissue Sarcoma

Stage IV Adult Soft Tissue Sarcoma

Endometrial Stromal Sarcoma

Stage IV Uterine Sarcoma

Uterine Leiomyosarcoma

Recurrent Adult Soft Tissue Sarcoma

Adult Fibrosarcoma

Stage III Uterine Sarcoma

Recurrent Uterine Sarcoma

Adult Malignant Fibrous Histiocytoma

Uterine Carcinosarcoma

Dermatofibrosarcoma Protuberans

Adult Rhabdomyosarcoma

Adult Liposarcoma

Adult Leiomyosarcoma

Treatments

Drug: saracatinib

Study type

Interventional

Funder types

NIH

Identifiers

NCT00659360

CDR0000588034 (Other Grant/Funding Number)

PHL-054 (Other Grant/Funding Number)

NCI-2009-01054

PMH-PHL-054 (Other Grant/Funding Number)

N01CM62203 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

I. To assess the efficacy of AZD0530, in terms of disease control rate (i.e., response rate and stable disease rate), in patients with recurrent locally advanced or metastatic soft tissue sarcoma.

II. To assess the toxicity, time to progression, and response duration of AZD0530 in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 8 weeks.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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