Oncology In the Department of Medicine

Heather Wakelee

AZD0530 in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer

Contact Information

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Melanie San Pedro-Salcedo (650) 724-1388
To view all clinical trials at Stanford, please see the Clinical Trials Directory.

Brief

RATIONALE: AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well AZD0530 works in treating patients with relapsed or refractory thymoma or thymic cancer.

Recruiting Status:

Recruiting

Stanford Recruiting Status:

Recruiting

Condition(s):

Intervention(s):

  • Drug: AZD0530

Phase:

Phase 2

Eligibility

Ages Eligible for Study:

18 years to Any Age

Genders Eligible for Study:

Male and Female

Health of Volunteers:

People with the conditions listed in this trial can participate as controls.

Key Inclusion Criteria:

DISEASE CHARACTERISTICS:

- Histologically confirmed invasive thymoma or thymic carcinoma, meeting the following criteria:
o Relapsed or refractory disease
o Metastatic, unresectable disease
a. Locally invasive disease allowed provided it is not resectable and has been previously treated
o Progressive disease

- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan

- Must have received >= 1 prior chemotherapy regimen

- No active brain metastases
o Patients with previously treated brain metastases (surgical resection or radiotherapy) are eligible provided they have documented stable brain disease for >= 1 month after completion of therapy and are asymptomatic

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Leukocytes >= 3,000/mm^3

- ANC >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Hemoglobin > 9 g/dL

- Serum bilirubin < 2.0 times upper limit of normal (ULN)

- Transaminases <= 2.5 times ULN (< 5.0 times ULN if liver metastasis is present)

- Serum creatinine < 1.5 times ULN OR creatinine clearance > 50 mL/min

- Urine protein:creatinine ratio < 0.5 OR urine protein < 1,000 mg by 24-hour urine collection

- QTc < 460 msec

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after completion of study treatment

- No known history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530

- No other malignancies within the past 3 years, except curatively treated in situ carcinoma of the cervix or completely resected nonmelanoma skin cancer

- No concurrent active malignancies other than thymic malignancy

- No condition that impairs the ability to swallow AZD0350 tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease)

- No cardiac dysfunction including, but not limited to, any of the following:
o Symptomatic congestive heart failure
o Unstable angina pectoris
o Cardiac arrhythmia
o History of ischemic heart disease
o Myocardial infarction within the past year

- No QTc prolongation or other significant ECG abnormalities

- No poorly controlled hypertension (i.e., systolic blood pressure [BP] >= 150 mm Hg or diastolic BP >= 95 mm Hg)

- No evidence of severe or uncontrolled systemic conditions that would make it undesirable to participate in the study or that would jeopardize compliance with the study, including any of the following:
o Severe hepatic impairment
o Interstitial lung disease (bilateral, diffuse, or parenchymal lung disease)
o Unstable or uncompensated respiratory condition
o Unstable or uncompensated cardiac condition

- No uncontrolled illness including, but not limited to, any of the following:
o Ongoing or active infection
o Mental health issues or social circumstances that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior src inhibitors

- At least 4 weeks since prior systemic therapy (6 weeks for carmustine or mitomycin C)

- At least 8 weeks since prior immunotherapy

- At least 4 weeks since prior octreotide
o Concurrent octreotide for pure red cell aplasia allowed provided patient continues on the same dose and schedule, has had a response to this drug, and has demonstrated progressive thymoma by radiography or physical exam

- At least 4 weeks since prior surgery and recovered

- At least 4 weeks since prior investigational agents

- At least 4 weeks since prior radiotherapy to measurable disease sites (2 weeks for palliative radiotherapy to metastatic sites) and recovered

- At least 7 days since prior and no concurrent active CYP3A4 agents or substances

- No other concurrent investigational or anticancer agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

- Concurrent steroids allowed for treatment of a pre-existing autoimmune disorder or as antiemetic therapy

Key Exclusion Criteria:

Additional Study Details

Official Title:

Phase II Trial of AZD0530 for Patients With Relapsed/Refractory Thymic Malignancies (Thymoma and Thymic Carcinoma)

Anticipated start date:

7/27/2009

Lead Sponsor:

AstraZeneca

Collaborator(s):

  • NCI
  • Indiana University Melvin and Bren Simon Cancer Center

Investigator(s):

Study Type:

Interventional

Purpose:

Treatment

Allocation:

Non-randomized

Masking:

Open

Control:

none

Assignment:

Single Group

Endpoints:

Safety/Efficacy

Primary Outcomes:

  • Objective response rate (complete and partial response)

Secondary Outcomes:

  • Toxicity
  • Progression-free survival
  • Overall survival
  • Disease control rate

Total Number to be Enrolled:

49

Total Number to be Enrolled at Stanford:

15

More Information

Trial Unique Id: SU-08152008-1279

Secondary ID(s):

  • CDR0000599991
  • IUCRO-0214
  • IUMC-IUCRO-0214
  • NCT00718809
  • THOR0002

Locations & Contacts

Stanford Locations & Contacts:

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Melanie San Pedro-Salcedo (650) 724-1388

Non-Stanford Locations:

This study is being conducted at multiple locations, including non-Stanford locations.

This listing was last updated:

9/2/2009

PLEASE NOTE:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.

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