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Erlotinib With or Without IMC-A12 in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: University of Colorado at Denver and Health Sciences Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00778167
  Purpose

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as IMC-A12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether erlotinib is more effective when given together with or without IMC-A12 in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying the side effects and best dose of IMC-A12 and to see how well erlotinib works when given together with or without IMC-A12 in treating patients with stage III or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cixutumumab
Drug: erlotinib hydrochloride
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate Erlotinib Erlotinib hydrochloride Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label
Official Title: A Randomized Phase II Cross Over Study With a Safety Lead In of the Anti-IGF-1R Monoclonal Antibody IMC-A12 in Combination With Erlotinib Compared With Erlotinib Alone in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Failed At Least One Platinum Containing Chemotherapy Regimen.

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

Primary Outcome Measures:
  • Median time to progression [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2008
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Active Comparator
Patients receive oral erlotinib hydrochloride once daily on days 1-28.
Drug: erlotinib hydrochloride
Given orally
Arm II: Experimental
Patients receive oral erlotinib hydrochloride as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour on days 1, 8, 15, and 22.
Drug: cixutumumab
Given IV
Drug: erlotinib hydrochloride
Given orally

  Show Detailed Description

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

    • Stage IIIA, IIIB, or IV disease
    • Mixed histology permitted provided small-cell elements are not present
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Must have failed ≥ 1 platinum-containing chemotherapy regimen
  • CNS metastases are eligible if received prior radiotherapy to site(s) of CNS metastatic disease, or have had definitive resection of CNS metastatic disease and have no overt evidence of neurological deficits, are not requiring anti-epileptics, remain asymptomatic, and have been off steroids for ≥ 8 weeks

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 3 months
  • Leukocytes ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Hemoglobin ≥ 9 g/dL
  • Platelets ≥ 100,000/mm³
  • Total bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Fasting serum glucose < 120 mg/dL OR normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to anti-IGF-1R recombinant monoclonal antibody IMC-A122 or erlotinib hydrochloride
  • No poorly controlled diabetes mellitus

    • Patients with a history of diabetes mellitus are eligible, provided their blood glucose is within normal range at screening and they are on a stable dietary or therapeutic regimen for this condition
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situation that would limit compliance with study requirements
  • No inability to take oral medications or, in the investigator's opinion, gastrointestinal conditions or abnormalities likely to influence the absorption of oral medications

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy with acute effects resolved to ≤ grade 1
  • At least 28 days since prior anticancer or investigational agent (within predicted 5 half-lives of agent)
  • More than 4 weeks since prior radiotherapy to target lesions and documented disease progression at these sites
  • More than 2 weeks since prior radiotherapy to non-target lesions
  • More than 4 months since prior major surgery or hormonal therapy (other than replacement)
  • No prior or concurrent exposure to other EGFR or IGFR inhibitors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778167

Locations
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center     720-848-0650        
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute     877-275-7724        
Sponsors and Collaborators
University of Colorado at Denver and Health Sciences Center
Investigators
Study Chair: David R. Camidge, MD, PhD University of Colorado at Denver and Health Sciences Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000617094, UCHSC-08-0044
Study First Received: October 22, 2008
Last Updated: December 5, 2008
ClinicalTrials.gov Identifier: NCT00778167  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Study placed in the following topic categories:
Erlotinib
Antibodies, Monoclonal
Thoracic Neoplasms
Antibodies
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Immunoglobulins
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009