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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
NSCLC

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the objective response rate (ORR) in each study arm

Outcome Time Frame:

Approximately 1.5 years

Safety Issue:

No

Principal Investigator

Folker Schneller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Technical University, Munich

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

BT-CL-PGG-LCA0822

NCT ID:

NCT00874848

Start Date:

August 2009

Completion Date:

March 2013

Related Keywords:

  • NSCLC
  • Imprime PGG
  • NSCLC
  • Cetuximab
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of MinnesotaMinneapolis, Minnesota  55455
Medical College of GeorgiaAugusta, Georgia  30912
Mary Crowley Medical Research CenterDallas, Texas  75246
Allison Cancer CenterMidland, Texas  79701
Providence Medical GroupTerre Haute, Indiana  47802