Clinical trial NCT00659360: AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma
Official title: A Phase 2 Study of AZD0530 in Recurrent or Metastatic Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-04-16
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Up to 5 years
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Up to 5 years
measure: Overall Survival
timeFrame: Up to 5 years
measure: Stable Disease Rate
timeFrame: Up to 5 years
measure: Duration of Response
timeFrame: Up to 5 years
measure: Time to Disease Progression
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Rockledge
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Toronto
country: Canada
facility: University Health Network-Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: University Health Network-Princess Margaret Hospital
name: Margaret von Mehren
role: PRINCIPAL_INVESTIGATOR
References: