The Online Asbestos, Asbestos Cancer, & Mesothelioma Authority

Clinical Trials

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

Study Start Date: Â	December 2001
Primary Completion Date: Â	February 2005 (Final data collection date for primary outcome measure)

Detailed Description:

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor, including gliomas and the following epithelial malignancies:
  • Non-small cell lung
  • Mesothelioma
  • Breast
  • Head and neck
  • Esophageal
  • Pancreatic
  • Bladder
  • Prostate
  • Ovarian
  • Anal
  • Colorectal carcinoma
  • Cervical carcinoma
  • Hepatocellular carcinoma
• Metastatic or unresectable disease
• Standard curative or palliative therapy does not exist or is no longer effective
• Epidermal growth factor receptor (EGFR) positive
• Hepatic or renal dysfunction defined as one of the following:
  • Direct bilirubin 1.0-7.0 mg/dL with any AST
  • Albumin less than 2.5 g/dL
  • Creatinine 2.5-5.0 mg/dL
• Brain metastases allowed provided patient is asymptomatic, previously treated, has stable disease for at least 2 months, and is not currently receiving steroid therapy
• Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Male or female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• See Disease Characteristics
• No evidence of biliary obstruction

Renal:

• See Disease Characteristics
• No evidence of renal obstruction

Cardiovascular:

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Gastrointestinal:

• No gastrointestinal tract disease that would preclude ability to take oral medications
• No requirement for IV alimentation
• No active peptic ulcer disease

Ophthalmic:

• No prior corneal abnormalities (e.g., dry eye syndrome or Sjogren's syndrome)
• No prior congenital abnormality (e.g., Fuch's dystrophy)
• No prior abnormal slit-lamp exam using a vital dye (e.g., fluorescein or Bengal-Rose)
• No prior abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)

Other:

• No other concurrent uncontrolled illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for melphalan or mitomycin)
• No prior nitrosoureas

Endocrine therapy:

• See Disease Characteristics
• No concurrent steroids

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• At least 4 weeks since prior major surgery
• No prior surgical procedures affecting absorption

Other:

• No prior EGFR-targeting therapies, including gefitinib or Imclone C-225
• At least 3 months since prior suramin
• More than 7 days since prior grapefruit juice
• More than 7 days since other prior CYP3A4 inhibitors
• No concurrent grapefruit juice
• No concurrent CYP3A4 inducers, substrates, or other inhibitors
• No concurrent medications known to affect hepatic or renal function, including antiseizure medication or nonsteroidal anti-inflammatory agents
• No concurrent combination anti-retroviral therapy for HIV-positive patients

advanced malignant mesothelioma   recurrent malignant mesothelioma   stage IV colon cancer   stage IV breast cancer   recurrent breast cancer   recurrent non-small cell lung cancer   stage II pancreatic cancer   stage III pancreatic cancer   recurrent pancreatic cancer   stage IV rectal cancer Â

recurrent colon cancer recurrent rectal cancer stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer recurrent esophageal cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer recurrent adult brain tumor recurrent bladder cancer

Glioblastoma Carcinoma, Hepatocellular Esophageal Neoplasms Squamous cell carcinoma Sodium Salicylate Ovarian epithelial cancer Adenoid cystic carcinoma Ependymoma Carcinoma, Adenoid Cystic Metastatic squamous neck cancer with occult primary

Carcinoma, squamous cell Laryngeal carcinoma Glioma Papilloma Rectal cancer Esophageal neoplasm Bladder neoplasm Hepatocellular carcinoma Erlotinib Non-small cell lung cancer

Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions