Clinical trial NCT00870870: A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before
Official title: Randomized, Open Label, Stratified Phase 2 Trial of Gemcitabine, Carboplatin, and Cetuximab With Vs. Without IMC-A12 in Chemotherapy-Naive Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Tumors
Antibodies, Monoclonal
Stage IIIb Metastatic Non-Small Cell Lung Cancer
Stage IV Metastatic Non-Small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2009-03-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
timeFrame: Randomization to measured progressive disease (PD) (up to 16.9 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization to death due to any cause or censor (up to 30.4 months)
measure: Progression-Free Survival (PFS)
timeFrame: Randomization to PD or death due to any cause or censor (up to 16.9 months)
measure: Time To Progression (TTP)
timeFrame: Randomization to months until PD or censor (up to 16.9 months)
measure: Duration of Response
timeFrame: Date of first response to the date of PD or death due to any cause or censor ( up to 15.5 months)
measure: Number of Participants With Adverse Events (AEs) or Deaths
timeFrame: Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up
measure: Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity)
timeFrame: Prior to first infusions of Cycles 1, 3, and 5 and 30 days following the end of therapy
measure: Maximum Concentration (Cmax) of Cixutumumab at Study Day 1
timeFrame: Day 1
measure: Cmax of Cixutumumab for Cycle 1
timeFrame: Week 1 (Cycle 1, Day 1)
measure: Cmax of Cixutumumab for Cycle 3
timeFrame: Week 7 (Cycle 3, Day 1)
measure: Cmax of Cixutumumab Cycle 5
timeFrame: Week 13 (Cycle 5, Day 1)
measure: Minimum Concentration (Cmin) of Cixutumumab at Study Day 1
timeFrame: Day 1
measure: Cmin of Cixutumumab for Cycle 1
timeFrame: Week 1 (Cycle 1, Day 1)
measure: Cmin of Cixutumumab for Cycle 3
timeFrame: Week 7 (Cycle 3, Day 1)
measure: Cmin of Cixutumumab for Cycle 5
timeFrame: Week 13 (Cycle 5, Day 1)
Other outcomes:
Locations:
city: Anniston
country: United States
facility: ImClone Investigational Site
state: Alabama
city: La Jolla
country: United States
facility: ImClone Investigational Site
state: California
city: Orange
country: United States
facility: ImClone Investigational Site
state: California
city: Orlando
country: United States
facility: ImClone Investigational Site
state: Florida
city: Atlanta
country: United States
facility: ImClone Investigational Site
state: Georgia
city: Chicago
country: United States
facility: ImClone Investigational Site
state: Illinois
city: Chicago
country: United States
facility: ImClone Investigational Site
state: Illinois
city: Albuquerque
country: United States
facility: ImClone Investigational Site
state: New Mexico
city: New York
country: United States
facility: ImClone Investigational Site
state: New York
city: New York
country: United States
facility: ImClone Investigational Site
state: New York
city: New York
country: United States
facility: ImClone Investigational Site
state: New York
city: Cincinnati
country: United States
facility: ImClone Investigational Site
state: Ohio
Study officials:
affiliation: Eli Lilly and Company
name: E-mail: ClinicalTrials@ ImClone.com
role: STUDY_DIRECTOR
References: