The Online Asbestos, Asbestos Cancer, & Mesothelioma Authority

Clinical Trials

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	40
Study Start Date:	November 2005
Estimated Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

• Histologically confirmed epithelial, sarcomatous, or biphasic malignant pleural mesothelioma
  • Unresectable disease
    • Residual disease after prior cytoreductive surgery allowed
• Measurable disease by CT scan or MRI
• Prior treatment with platinum-based chemotherapy required
• No known CNS metastasis

PATIENT CHARACTERISTICS:

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• AST or ALT ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin normal

Renal

• Creatinine ≤ 1.5 times ULN OR
• Creatinine clearance ≥ 50 mL/min
• Proteinuria ≤ 1+ by 2 consecutive dipstick tests taken ≥ 1 week apart

Cardiovascular

• No history of familial long QT syndrome
• Mean QTc ≤ 470 msec
• Systolic BP ≤ 150 mm Hg AND diastolic BP ≤ 100 mm Hg
• Must have New York Heart Association class I or II disease
  • Class II must be controlled with treatment

Gastrointestinal

• Able to swallow and/or receive enteral medications via gastrostomy feeding tube
• Not requiring IV alimentation
• No active peptic ulcer
• No intractable nausea or vomiting

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in remission
• No history of hypersensitivity reaction to compounds of similar chemical or biological composition to the study drug

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior monoclonal antibody therapy targeting vascular endothelial growth factor (VEGF), VEGF receptor 1 (VEGFR1) or VEGF receptor 2 (VEGFR2) allowed
• No other prior immunotherapy or biologic therapy
• No prior thymidine kinase inhibitor against VEGFR1 or VEGFR2
• No concurrent drugs or biologics with proarrythmic potential

Chemotherapy

• See Disease Characteristics
• No more than 1 prior chemotherapy regimen
• At least 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin) and recovered

Radiotherapy

• At least 21 days since prior radiotherapy and recovered

Surgery

• See Disease Characteristics
• At least 28 days since prior major surgery (e.g., thoracotomy or laparotomy) and recovered
• No prior surgery that would affect absorption

Other

• Stable antihypertensive therapy allowed provided blood pressure (BP) parameters are met
• Concurrent enrollment on SWOG-S9925 allowed
• No concurrent combination antiretroviral therapy for HIV-positive patients

epithelial mesothelioma sarcomatous mesothelioma advanced malignant mesothelioma recurrent malignant mesothelioma

Mesothelioma Adenoma Recurrence Neoplasms, Glandular and Epithelial

Neoplasms Neoplasms by Histologic Type Mesothelioma Neoplasms, Mesothelial