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Efficacy/Safety of Imprime PGG® Injection With Cetuximab and Paclitaxel/Carboplatin Therapy in Patients With Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biothera
ClinicalTrials.gov Identifier:
NCT00874848
First received: April 1, 2009
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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 and carboplatin therapy in patients with previously untreated advanced NSCLC. Additionally, this study will provide guidance for the design of more definitive efficacy studies of Imprime PGG in NSCLC patients.


Condition Intervention Phase
NSCLC
Biological: Imprime PGG® Injection
Biological: Cetuximab
Drug: Paclitaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Imprime PGG® Injection in Combination With Cetuximab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Biothera:

Primary Outcome Measures:
  • To determine the objective response rate (ORR) in each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the disease control rate (DCR) in each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]
  • To determine the complete response (CR), partial response (PR), and stable disease (SD) rates in each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]
  • To determine the duration of objective tumor response in each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]
  • To determine the duration of stable disease in each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]
  • To determine the duration of time to progression (TTP) in each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]
  • To assess the safety of the dosing regimen in each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: August 2009
Study Completion Date: September 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
Biological: Imprime PGG® Injection
4 mg/kg i.v. over 2 hrs, weekly, in three week cycles
Biological: Cetuximab
initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
Other Name: Erbitux
Drug: Paclitaxel
200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Drug: 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
2
Cetuximab + Paclitaxel/Carboplatin
Biological: Cetuximab
initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
Other Name: Erbitux
Drug: Paclitaxel
200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC)
  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:

  1. Has received prior systemic chemotherapy at any time for lung cancer;
  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
    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874848

Locations
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Indiana
Providence Medical Group
Terre Haute, Indiana, United States, 47802
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201
Allison Cancer Center
Midland, Texas, United States, 79701
Germany
Helios Clinic Emil von Behring
Berlin, Germany
Municipal Clinic Frankfurt Hoescht
Frankfurt, Germany
Georg-August University Gottingen
Gottingen, Germany, 37075
University Clinical Heidelberg
Heidelberg, Germany
Clinic Minden
Minden, Germany
Techincal University of Munich
Munich, Germany
Clinic Nurnberg Nord
Nuremberg, Germany
Universitätsklinikum Ulm
Ulm, Germany, 89081
HELIOS Klinikum Wuppertal, Medizinische Klinik 1
Wuppertal, Germany, 42283
Sponsors and Collaborators
Biothera
Investigators
Principal Investigator: Folker Schneller, MD Technical University, Munich
  More Information

No publications provided

Responsible Party: Biothera
ClinicalTrials.gov Identifier: NCT00874848     History of Changes
Other Study ID Numbers: BT-CL-PGG-LCA0822
Study First Received: April 1, 2009
Last Updated: March 3, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biothera:
Imprime PGG
NSCLC
Cetuximab

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Cetuximab
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014