Status:
COMPLETED
A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before
Lead Sponsor:
Eli Lilly and Company
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.
Detailed Description
Participants with Stage IIIb or IV non-small cell lung cancer (NSCLC) who have not received previous chemotherapy will be stratified, based on disease histology (squamous versus \[vs.\] nonsquamous).
Eligibility Criteria
Inclusion
- Has histologically or cytologically confirmed, Stage IIIb - IV NSCLC
- 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
- Has uncontrolled brain metastases
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00870870
Start Date
March 1 2009
End Date
May 1 2012
Last Update
June 1 2018
Active Locations (12)
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1
ImClone Investigational Site
Anniston, Alabama, United States, 36207
2
ImClone Investigational Site
La Jolla, California, United States, 92093
3
ImClone Investigational Site
Orange, California, United States, 92868
4
ImClone Investigational Site
Orlando, Florida, United States, 32806