Status:
COMPLETED
A Study of Ramucirumab (IMC-1121B) With Paclitaxel and Carboplatin in Non-small Cell Lung Cancer
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 evaluate the progression-free survival (PFS) rate at 6 months of ramucirumab administered in combination with paclitaxel and carboplatin as first-line therapy for Stage...
Detailed Description
Non-small cell lung cancer (NSCLC) accounts for 75-80% of all lung cancers. The advanced stages are associated with poor survival rates, a median survival rate of approximately 3.9 months if left untr...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed NSCLC
- Advanced NSCLC
- Measurable disease (as defined by Response Evaluation Criteria in Solid Tumors \[RECIST 1.0\])
- Eastern Cooperative Oncology Group (ECOG) Performance Status is ≤ 1
- Age ≥ 18 years
- Adequate hematologic function = an absolute neutrophil count (ANC) ≥ 1500/μL, hemoglobin ≥ 9 g/dL, and a platelet count ≥ 100,000/microliter (μL)
- Adequate hepatic function = a total bilirubin ≤ 1.5 mg/dL transaminases and alkaline phosphatase ≤ 5 x the upper limit of normal (ULN)
- Adequate renal function serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance (CrCl) \> 60 mL/minute, and urine dipstick for protein \< 1+ (ie, either 0 or trace)
- Adequate coagulation function, INR ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above ULN
- Adequate contraception
- Signed informed consent
Exclusion
- Untreated CNS metastases
- Prior bevacizumab therapy
- Radiologically documented evidence of major blood vessel invasion or encasement by cancer
- Prior systemic chemotherapy for Stage IIIB/IV NSCLC
- Prior systemic chemotherapy or radiation therapy for Stage I-IIIA NSCLC \< 1 year prior
- Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix
- Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy
- Ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Uncontrolled thrombotic or hemorrhagic disorders
- Poorly-controlled hypertension
- Chronic daily treatment with aspirin (\> 325 mg/day) or other known inhibitors of platelet function
- History of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon)
- Serious non-healing wound, ulcer, or bone fracture
- Undergone major surgery or subcutaneous venous access device placement. Post-operative bleeding complications or wound complications from a surgical procedures performed in the last 2 months
- Elective or a planned major surgery to be performed during the course of the trial
- Peripheral neuropathy ≥ Grade 2 (National Cancer Institute Common Toxicity Criteria for Adverse Events, Version 3.0 \[NCI-CTCAE v 3.0\])
- If female, is pregnant or lactating
- Radiographic evidence of intratumor cavitation
- Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00735696
Start Date
January 1 2009
End Date
January 1 2012
Last Update
December 29 2014
Active Locations (9)
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1
ImClone Investigational Site
Beverly Hills, California, United States, 90211
2
ImClone Investigational Site
San Francisco, California, United States, 94143
3
ImClone Investigational Site
Aurora, Colorado, United States, 80045
4
ImClone Investigational Site
New York, New York, United States, 10016