Status:
COMPLETED
Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
HiberCell, Inc.
Conditions:
NSCLC
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The Phase 2 study described in this protocol will serve to evaluate the antitumor activity, safety and pharmacokinetic profile of Imprime PGG when combined with cetuximab and concomitant paclitaxel an...
Eligibility Criteria
Inclusion
- Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC)
- Is between the ages of 18 and 75 years old, inclusive
- Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer
- Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST
- Has an ECOG performance status of 0 or 1
- Has a life expectancy of \> 3 months
- Has adequate hematologic function as evidenced by:
- ANC ≥ 1,500/μL
- PLT ≥ 100,000/μL
- HGB ≥ 9 g/dL obtained within 1 week prior to the first dose of study medication;
- Has adequate renal function as evidenced by:
- Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) for the reference lab
- Urine dipstick for proteinuria of \< 1+ (i.e., either 0 or trace) within 2 weeks of Day 1 If urine dipstick is ≥ 1+, then urine protein excretion must be ≤ 500 mg over a 24 hour collection obtained within 1 week prior to the first dose of study medication;
- Has adequate hepatic function as evidenced by:
- Serum total bilirubin ≤ 1.0 mg/dL
- AST ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
- ALT ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases) obtained within 1 week prior to the first dose of study medication;
- If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form of contraception (hormonal contraceptive, double-barrier method or abstinence) during the study.
Exclusion
- Has received prior systemic chemotherapy at any time for lung cancer;
- Has received previous radiation therapy to \>30% of active bone marrow or any radiation therapy within 3 weeks of Day 1
- Has a known hypersensitivity to baker's yeast, or has an active yeast infection
- Has had previous exposure to Betafectin® or Imprime PGG
- Has an active infection
- Presents with any of the following medical diagnoses/conditions at the time of screening:
- Central nervous system (CNS) metastases
- Uncontrolled hypertension (\>150/100 mmHg) or hypertension that requires \> two agents for adequate control
- Peripheral neuropathy ≥ grade 2 from any cause
- Fever of \>38.5° C within 3 days prior to screening or Day 1, initial dosing
- Known HIV/AIDs, Hepatitis B, Hepatitis C, connective tissue or autoimmune disease, or other clinical diagnosis, ongoing or intercurrent illness that in the physician's opinion could interfere with participation
- Has a history of any of the following medical diagnoses/conditions:
- Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure) within the previous 6 months
- Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intra-epithelial neoplasia or curatively treated prostate cancer with a PSA of \<2.0 ng/mL
- Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab
- Has a know sensitivity to Cremophor EL
- Has previously received treatment with cetuximab
- If female, is pregnant or breast-feeding
- Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication)
- Has previously received an organ or progenitor/stem cell transplant.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00874848
Start Date
August 1 2009
End Date
August 1 2015
Last Update
November 29 2016
Active Locations (14)
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1
Medical College of Georgia
Augusta, Georgia, United States, 30912
2
Providence Medical Group
Terre Haute, Indiana, United States, 47802
3
University of Minnesota
Minneapolis, Minnesota, United States, 55455
4
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201