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

January 15, 2013 updated by: National Cancer Institute (NCI)

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

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 tumor

Study Overview

Status

Completed

Conditions

Detailed Description

PRIMARY OBJECTIVES:

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60606
        • Cancer and Leukemia Group B

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment (erlotinib hydrochloride)
Patients receive oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Correlative studies
Given orally
Other Names:
  • OSI-774
  • erlotinib
  • CP-358,774

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose (MTD) of OSI-774 determined by dose-limiting toxicities
Time Frame: Within the first 4 weeks treatment
Within the first 4 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

February 14, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-01868
  • U10CA031946 (U.S. NIH Grant/Contract)
  • CALGB-60101
  • CDR0000069170 (REGISTRY: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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