A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before
NCT ID: NCT00870870
Last Updated: 2018-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2009-03-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GCiC + IMC-A12 (Gemcitabine/Cisplatin/Cetuximab + Cixutumumab)
Cycles repeat every 3 weeks for first 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met
\*Cisplatin will replace Carboplatin. Gemcitabine/Carboplatin/Cetuximab (GCC) plus cixutumumab will change to Gemcitabine/Cisplatin/Cetuximab (GCiC) plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab)
Gemcitabine
1000 milligrams per square meter (mg/m\^2) on Days 1 and 8 of each cycle
\[First 6 cycles (18 weeks)\]
Cisplatin
75 mg/m\^2 on Day 1 of each cycle
\[First 6 cycles (18 weeks)\]
IMC-A12 (cixutumumab)
6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle)
\[First 6 cycles (18 weeks)\]
Cetuximab
400 mg/m\^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m\^2 once per week thereafter
\[First 6 cycles (18 weeks)\]
IMC-A12 (cixutumumab)
10 mg/kg IV infusion, administered once every 2 weeks
(Maintenance therapy)
Cetuximab
500 mg/m\^2 IV infusion, administered once every 2 weeks
(Maintenance therapy)
Carboplatin
Area under the curve (AUC) = 5, Day 1 of each cycle
\[First 6 cycles (18 weeks)\]
\*Carboplatin will be replaced by Cisplatin
GCiC (Gemcitabine/Cisplatin/Cetuximab)
Cycles repeat every 3 weeks for 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met
\*Cisplatin will replace Carboplatin. GCC plus cixutumumab will change to GCiC plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab)
Gemcitabine
1000 milligrams per square meter (mg/m\^2) on Days 1 and 8 of each cycle
\[First 6 cycles (18 weeks)\]
Cisplatin
75 mg/m\^2 on Day 1 of each cycle
\[First 6 cycles (18 weeks)\]
Cetuximab
400 mg/m\^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m\^2 once per week thereafter
\[First 6 cycles (18 weeks)\]
Cetuximab
500 mg/m\^2 IV infusion, administered once every 2 weeks
(Maintenance therapy)
Carboplatin
Area under the curve (AUC) = 5, Day 1 of each cycle
\[First 6 cycles (18 weeks)\]
\*Carboplatin will be replaced by Cisplatin
Interventions
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Gemcitabine
1000 milligrams per square meter (mg/m\^2) on Days 1 and 8 of each cycle
\[First 6 cycles (18 weeks)\]
Cisplatin
75 mg/m\^2 on Day 1 of each cycle
\[First 6 cycles (18 weeks)\]
IMC-A12 (cixutumumab)
6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle)
\[First 6 cycles (18 weeks)\]
Cetuximab
400 mg/m\^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m\^2 once per week thereafter
\[First 6 cycles (18 weeks)\]
IMC-A12 (cixutumumab)
10 mg/kg IV infusion, administered once every 2 weeks
(Maintenance therapy)
Cetuximab
500 mg/m\^2 IV infusion, administered once every 2 weeks
(Maintenance therapy)
Carboplatin
Area under the curve (AUC) = 5, Day 1 of each cycle
\[First 6 cycles (18 weeks)\]
\*Carboplatin will be replaced by Cisplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has metastatic disease
* Has a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Has adequate hematologic function
* Has adequate hepatic function
* Has adequate renal function
* Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion Criteria
* Has leptomeningeal disease
* Has received previous chemotherapy for NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization)
* Receiving any other investigational agent(s)
* Has a history of treatment with other agents targeting the insulin-like growth factor (IGF) or the epidermal growth factor (EGF) receptor
* Has a known allergy / history of hypersensitivity reaction to any of the treatment components
* Has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range \[fasting glucose \<160 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN) and hemoglobin A1C≤ 7%\] and that they are on a stable dietary or therapeutic regimen for this condition
* Has an uncontrolled intercurrent illness
* Pregnant or lactating
* Has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years
* Has superior vena cava syndrome contraindicating hydration
* Has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure
* Has any National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version (v) 3.0 Grade ≥2 peripheral neuropathy
* Has significant third space fluid retention, requiring repeated drainage
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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E-mail: ClinicalTrials@ ImClone.com
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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ImClone Investigational Site
Anniston, Alabama, United States
ImClone Investigational Site
La Jolla, California, United States
ImClone Investigational Site
Orange, California, United States
ImClone Investigational Site
Orlando, Florida, United States
ImClone Investigational Site
Atlanta, Georgia, United States
ImClone Investigational Site
Chicago, Illinois, United States
ImClone Investigational Site
Chicago, Illinois, United States
ImClone Investigational Site
Albuquerque, New Mexico, United States
ImClone Investigational Site
New York, New York, United States
ImClone Investigational Site
New York, New York, United States
ImClone Investigational Site
New York, New York, United States
ImClone Investigational Site
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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CP02-0860
Identifier Type: OTHER
Identifier Source: secondary_id
CP13-0811
Identifier Type: OTHER
Identifier Source: secondary_id
I5A-IE-JAEF
Identifier Type: OTHER
Identifier Source: secondary_id
13930
Identifier Type: -
Identifier Source: org_study_id
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