Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction

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Brief Title

Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction

Official Title

Phase I Study of OSI-774 (NSC 718781) for Solid Tumors in Patients With Hepatic or Renal Dysfunction

Brief Summary

      Phase I trial to study the effectiveness of erlotinib in treating patients who have
      metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies
      such as erlotinib may interfere with the growth of tumor cells and slow the growth of the

Detailed Description


      I. Determine the maximum tolerated dose of erlotinib in patients with solid tumors and
      hepatic or renal dysfunction.

      II. Determine the pharmacokinetics of this drug in these patients.

      OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
      hepatic or renal dysfunction (albumin less than 2.5 g/dL, direct bilirubin less than 1.0
      mg/dL, any AST, and creatinine normal vs direct bilirubin 1.0-7.0 mg/dL, any AST, and
      creatinine normal vs creatinine 2.5-5.0 mg/dL, albumin 2.5 g/dL or greater, AST less than 3
      times upper limit of normal, and direct bilirubin less than 1.0 mg/dL).

      Patients receive oral erlotinib once daily. Treatment continues in the absence of disease
      progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
      of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at
      least 6 evaluable patients are treated at that dose.

Study Phase

Phase 1

Study Type


Primary Outcome

Maximum tolerated dose (MTD) of OSI-774 determined by dose-limiting toxicities


Adult Anaplastic Astrocytoma


erlotinib hydrochloride

Study Arms / Comparison Groups

 Treatment (erlotinib hydrochloride)
Description:  Patients receive oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

December 2001

Primary Completion Date

July 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed solid tumor, including gliomas and the following epithelial

               -  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

          -  Male or female

          -  Performance status - ECOG 0-2

          -  Granulocyte count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  See Disease Characteristics

          -  No evidence of biliary obstruction

          -  See Disease Characteristics

          -  No evidence of renal obstruction

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  No gastrointestinal tract disease that would preclude ability to take oral medications

          -  No requirement for IV alimentation

          -  No active peptic ulcer disease

          -  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)

          -  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

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

          -  At least 4 weeks since prior chemotherapy (6 weeks for melphalan or mitomycin)

          -  No prior nitrosoureas

          -  See Disease Characteristics

          -  No concurrent steroids

          -  At least 4 weeks since prior radiotherapy

          -  At least 4 weeks since prior major surgery

          -  No prior surgical procedures affecting absorption

          -  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




18 Years - N/A

Accepts Healthy Volunteers



Antonius Miller, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

Antonius Miller, Principal Investigator, Cancer and Leukemia Group B

Verification Date

January 2013