Erlotinib Hydrochloride With or Without Cixutumumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Phase I/Randomized Phase II Study 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)
8 other identifiers
interventional
18
1 country
2
Brief Summary
This randomized phase I/II trial is studying the side effects and best dose of cixutumumab and to see how well erlotinib hydrochloride works when given together with or without cixutumumab in treating patients with stage III or stage IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cixutumumab, 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 hydrochloride is more effective when given together with or without cixutumumab in treating non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2008
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 22, 2008
CompletedFirst Posted
Study publicly available on registry
October 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
April 23, 2013
CompletedMay 21, 2014
March 1, 2013
3.6 years
October 22, 2008
January 15, 2013
May 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability of IMC-A12 in Combination With Erlotinib Hydrochloride as Graded by Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0 (DLTs During Cycle One)
Patients were evaluable for cohort dose escalation/de-escalation decision making either if they experienced DLTs in cycle 1 or if they had completed 24 of the planned 28 days (85%) dosing of erlotinib and three of the four planned days of weekly dosing of cixutumumab (75%) in cycle 1 in cohorts 1 and 2 in the absence of DLTs. In cohort 3, patients were evaluable for tolerability if they had completed 18 days (85%) dosing of erlotinib and had received the planned day 1 dose of cixutumumab.
From time of first dose up to 28 days
Study Arms (2)
Arm I (Enzyme inhibitor therapy)
EXPERIMENTALPatients receive erlotinib hydrochloride PO once daily on days 1-21. Patients with documented disease progression may cross over and receive treatment on arm II.
Arm II (Enzyme inhibitor and monoclonal antibody therapy)
EXPERIMENTALPatients receive erlotinib hydrochloride PO as in arm I and cixutumumab IV over 1 hour on days 1, 8, and 15.
Interventions
Given IV
Given PO
Correlative studies
Eligibility Criteria
You may qualify if:
- 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 ≥ 1unidimensionally 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
- 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
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Colorado
Denver, Colorado, 80217-3364, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Phase I of the study was completed but because of concerns about the achievable dose intensity at the maximum tolerated dose (MTD), the expansion into a randomized phase II study comparing full-dose erlotinib with the combination was cancelled.
Results Point of Contact
- Title
- Dr. David R. Camidge
- Organization
- University of Colorado Denver
Study Officials
- PRINCIPAL INVESTIGATOR
David Camidge
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2008
First Posted
October 23, 2008
Study Start
October 1, 2008
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 21, 2014
Results First Posted
April 23, 2013
Record last verified: 2013-03