Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

OSI-774 in African American Patients With Advanced and Previously Treated Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Miguel Villalona, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00230126
First received: September 28, 2005
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

This study determines tumor response rate, time to tumor progression and survival rate at 1 year produced by OSI-774 in previously treated African American patients with nonsmall cell lung cancer.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study of OSI-774 in African American Patients With Advanced and Previously Treated Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Disease Control Rate at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    no progression of disease at 12 weeks from starting treatment

  • Time to Progression [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • 1-year Survival Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: October 2005
Study Completion Date: July 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A erlotinib 150 mg
erlotinib 150 mg/day cycles 1 - 3
Drug: erlotinib
Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.
Other Name: Tarceva
Experimental: B erlotinib modified according to weight
erlotinib Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to skin rash.
Drug: erlotinib
Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.
Other Name: Tarceva

Detailed Description:

Rationale: Researchers are seeking to identify treatment regimens with low toxicity for non-small cell lung cancer (NSCLC), especially for African Americans with this disease who seem to have a larger burden of comorbidities and decreased performance status. The current study uses a drug called OSI-774 in previously treated African American patients with NSCLC. OSI-774 is a targeted agent designed as an EGFR tyrosine kinase inhibitor. Previous research indicates that tumor cells overexpress EGFR receptors, and this drug works by blocking these receptors on tumor cells that that help them grow.

OSI-774 is FDA approved for the treatment of patients with non-small cell lung cancer that had been previously treated with chemotherapy. Unfortunately, very little data exist in the pharmacokinetics and metabolism of EGFR blockers in African Americans and in the assessment of how efficacious these agents are in this patient group. Yet, research suggests that EGFR blockage may have a greater impact on this patient population. Since the development of skin rash following therapy with EGFR blockers may be a surrogate of obtaining sufficient concentrations at the tissue level and potential efficacy, the current study is a randomized phase II trial designed to compare normal dose levels of OSI-774 with dose levels determined by body weight and with subsequent amounts adjusted further into the study to generate a skin rash. Through the current study, researchers are testing their theory that this dosing method will increase the number of patients with effective tissue concentrations and result in an increase in patient responses.

Purpose: The primary objective of this study is to determine the objective tumor response rate, the time to tumor progression, and the survival rate at one year produced by OSI-774 in previously treated African American patients with advanced NSCLC. A second objective is to evaluate if a regimen of single agent OSI-774, with dosing initially influenced by body weight and with subsequent titration to achieve skin rash is a suitable regimen for future studies of this agent. A third objective is to measure if changes in EGFR from tumor and blood cells correlate with the development of rash and clinical benefit. The pharmacokinetics of OSI-774 will also be characterized through study participants.

Treatment: Patients in this study will be given OSI-774. A computer will randomly assign patients into one of two treatment groups. Group one will be given a standard dose of OSI-774. The dose of OSI-774 will not be increased in group one. However, patients in group one will have the dose level decreased due to unacceptable side effects. Group two will receive OSI-774 at a dose modified to their body weight at study entry and subsequently adjusted further into the study to generate a skin rash. For all study participants, OSI-774 will be administered daily in oral pills. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have histologically or cytologically confirmed stage IIIB or IV NSCLC treated with 1-2 platinum- or taxane-containing regimens
  • Measurable disease
  • May have had prior surgery & external beam radiation
  • African American
  • 18 years or older

Exclusion Criteria:

  • Known brain mets
  • Prior treatment with EGFR targeting therapies
  • Pregnant/lactating women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230126

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Miguel Villalona
Genentech, Inc.
Investigators
Principal Investigator: Miguel Villalona, M.D. Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Miguel Villalona, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00230126     History of Changes
Other Study ID Numbers: OSU-0443, NCI-2011-03221
Study First Received: September 28, 2005
Results First Received: April 15, 2014
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University Comprehensive Cancer Center:
African Americans

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014