Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer
NCT ID: NCT00874848
Last Updated: 2016-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2009-08-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Imprime PGG
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
Imprime PGG Injection
4 mg/kg i.v. over 2 hrs, weekly, in three week cycles
Cetuximab
initial loading dose of 400 mg/m\^2 over 120 min and subsequent doses at 250 mg/m\^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
Paclitaxel
200 mg/m\^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Carboplatin
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Control
Cetuximab + Paclitaxel/Carboplatin
Cetuximab
initial loading dose of 400 mg/m\^2 over 120 min and subsequent doses at 250 mg/m\^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
Paclitaxel
200 mg/m\^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Carboplatin
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Interventions
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Imprime PGG Injection
4 mg/kg i.v. over 2 hrs, weekly, in three week cycles
Cetuximab
initial loading dose of 400 mg/m\^2 over 120 min and subsequent doses at 250 mg/m\^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
Paclitaxel
200 mg/m\^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Carboplatin
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Is between the ages of 18 and 75 years old, inclusive
3. Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer
4. Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST
5. Has an ECOG performance status of 0 or 1
6. Has a life expectancy of \> 3 months
7. 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;
8. 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;
9. 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;
10. 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 Criteria
2. Has received previous radiation therapy to \>30% of active bone marrow or any radiation therapy within 3 weeks of Day 1
3. Has a known hypersensitivity to baker's yeast, or has an active yeast infection
4. Has had previous exposure to Betafectin® or Imprime PGG
5. Has an active infection
6. 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
7. 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
8. Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab
9. Has a know sensitivity to Cremophor EL
10. Has previously received treatment with cetuximab
11. If female, is pregnant or breast-feeding
12. 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)
13. Has previously received an organ or progenitor/stem cell transplant.
18 Years
75 Years
ALL
No
Sponsors
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HiberCell, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Folker Schneller, MD
Role: PRINCIPAL_INVESTIGATOR
Technical University, Munich
Locations
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Medical College of Georgia
Augusta, Georgia, United States
Providence Medical Group
Terre Haute, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Allison Cancer Center
Midland, Texas, United States
Helios Clinic Emil von Behring
Berlin, , Germany
Municipal Clinic Frankfurt Hoescht
Frankfurt, , Germany
Georg-August University Gottingen
Göttingen, , Germany
University Clinical Heidelberg
Heidelberg, , Germany
Clinic Minden
Minden, , Germany
Techincal University of Munich
Munich, , Germany
Clinic Nurnberg Nord
Nuremberg, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
HELIOS Klinikum Wuppertal, Medizinische Klinik 1
Wuppertal, , Germany
Countries
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References
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Thomas M, Sadjadian P, Kollmeier J, Lowe J, Mattson P, Trout JR, Gargano M, Patchen ML, Walsh R, Beliveau M, Marier JF, Bose N, Gorden K, Schneller F 3rd. A randomized, open-label, multicenter, phase II study evaluating the efficacy and safety of BTH1677 (1,3-1,6 beta glucan; Imprime PGG) in combination with cetuximab and chemotherapy in patients with advanced non-small cell lung cancer. Invest New Drugs. 2017 Jun;35(3):345-358. doi: 10.1007/s10637-017-0450-3. Epub 2017 Mar 16.
Other Identifiers
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BT-CL-PGG-LCA0822
Identifier Type: -
Identifier Source: org_study_id