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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biothera
ClinicalTrials.gov Identifier:
NCT00874107
First received: April 1, 2009
Last updated: March 13, 2013
Last verified: March 2013
  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 bevacizumab 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
Non-Small Cell Lung Cancer
Biological: Imprime PGG® Injection
Biological: Bevacizumab
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: A Phase 2, Randomized, Efficacy and Safety Study of Imprime PGG® Injection in Combination With Bevacizumab 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 within each study arm [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: Yes ]
  • To determine the pharmacokinetic (PK) profile of Imprime PGG (in active treatment arm only) [ Time Frame: Approximately 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Imprime PGG + bevacizumab + paclitaxel/carboplatin
Biological: Imprime PGG® Injection
4 mg/kg, i.v. over 2 hr, weekly until progression or discontinuation
Biological: Bevacizumab
15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle
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
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
bevacizumab + paclitaxel/carboplatin
Biological: Bevacizumab
15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle
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
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 non-squamous, non-small cell lung cancer
  5. Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST;
  6. Has an ECOG performance status of 0 or 1;
  7. Has a life expectancy of > 3 months;
  8. Has adequate hematologic function as evidenced by:

    1. ANC ≥ 1,500/μL
    2. PLT ≥ 100,000/μL
    3. HGB ≥ 9 g/dL obtained within 1 week prior to the first dose of study medication;
  9. Has adequate renal function as evidenced by:

    1. Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) for the reference lab
    2. 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;
  10. Has adequate hepatic function as evidenced by:

    1. Serum total bilirubin ≤ 1.0 mg/dL
    2. AST ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
    3. 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;
  11. Has adequate coagulation function as evidenced by:

    1. INR ≤ 1.5
    2. PTT ≤ ULN for the reference lab obtained within 1 week prior to the first dose of study medication;
  12. 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:

    1. Central nervous system (CNS) metastases
    2. Uncontrolled hypertension (>150/100 mmHg) or hypertension that requires > two agents for adequate control
    3. Peripheral neuropathy ≥ grade 2 from any cause
    4. Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing
    5. 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:

    1. Arterial or venous thromboembolic or hemorrhagic disorders including stroke, transient ischemic attack or cerebral infarction
    2. Deep vein thrombosis within 1 year prior to screening
    3. 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
    4. 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 bevacizumab, murine proteins, or any component of bevacizumab;
  9. Has a know sensitivity to polyethoxylated castor oil;
  10. Has previously received treatment with bevacizumab;
  11. Has had surgery within 4 weeks of Day 1 or needle or open biopsy within 1 week of Day 1;
  12. Has a non-healing wound or gastric ulcer;
  13. Has a non-healed bone fracture;
  14. Is receiving systemic anti-coagulation therapy (e.g., dipyridalmole (Persantine®), ticlopidine (Ticlid®), clopidogrel (Plavix®) and /or cilostazol (Pletal®);
  15. Is receiving chronic daily treatment with aspirin (>100 mg/day) or other nonsteroidal anti-inflammatory agents known to inhibit platelet function within 1 week of Day 1;
  16. Presents with any of the following medical diagnoses/conditions at the time of screening:

    a. Predominant squamous cell histology

  17. Has a history of any of the following medical diagnoses/conditions:

    1. Hemoptysis (≥ ½ tsp red blood)
    2. Bleeding diathesis or coagulopathy
  18. If female, is pregnant or breast-feeding;
  19. 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);
  20. 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: NCT00874107

Locations
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Texas
University of Texas Health Science Center, San Antonio
San Antonio, Texas, United States, 78229
Germany
Hospital Marth-Maria Halle Dolau
Halle/Saale, Germany
Clinical Kassel GmbH
Kassel, Germany
Kliniken der Stadt Köln gGmbH
Köln, Germany
University of Mainz
Mainz, Germany
University of Munich
Munich, Germany
Pius-Hospital Oldenburg
Oldenburg, Germany
Universitätsklinikum Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
Biothera
  More Information

Publications:
Responsible Party: Biothera
ClinicalTrials.gov Identifier: NCT00874107     History of Changes
Other Study ID Numbers: BT-CL-PGG-LCA0821
Study First Received: April 1, 2009
Last Updated: March 13, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biothera:
NSCLC
Phase 2
Randomized
Efficacy
Safety
Imprime PGG
Bevacizumab

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014