Carboplatin, Pemetrexed, and Panitumumab in Patients With Advanced Non-Squamous K-ras Wild Type NSCLC

NCT01042288 | Completed Phase 2 Results

• 1 other identifier: SCRI LUN 183
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this multicenter, Phase II trial is to examine the role of a well-tolerated novel agent, panitumumab, in combination with a modern platinum doublet regimen using carboplatin and pemetrexed, in patients with advanced non-squamous wild type K-ras non-small-cell lung cancer (NSCLC). If this treatment proves to be well tolerated and associated with efficacy, this would provide rationale for further randomized studies.

Conditions

Non-Small-Cell Lung Cancer

Keywords

Non-Small-Cell Lung Cancer; NSCLC; Panitumumab; Vectibix; Pemetrexed; Alimta; Carboplatin

Outcome Measures

Primary Outcomes (1)

• Median Time to Progression (TTP)

  Defined as the time between Day 1-Cycle 1 and date of first documented disease progression assessed using Response Evaluation Criteria in Solid Tumors (RECISTS) v1.1.

  18 months

Secondary Outcomes (4)

• Median Progression-free Survival (PFS)

  Assessments by clinical evaluation, radiographic status, and date of disease progression, estimated 18 months

• Median Overall Survival (OS)

  18 months

• Objective Response Rate

  Projected 18 months

• Frequency of Adverse Events and Severity as a Measure of Toxicity

  Every 3 weeks (1 cycle) for 6 cycles, then every 7 weeks thereafter

Study Arms (1)

Carboplatin/Pemetrexed/Panitumumab

EXPERIMENTAL

Systemic Therapy

Drug: Carboplatin; Drug: Pemetrexed; Drug: Panitumumab

Interventions

Carboplatin DRUG

Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)

Carboplatin/Pemetrexed/Panitumumab

Pemetrexed DRUG

Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)

Also known as: Alimta

Carboplatin/Pemetrexed/Panitumumab

Panitumumab DRUG

Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)

Also known as: Vectibix

Carboplatin/Pemetrexed/Panitumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Histologically confirmed non-squamous NSCLC (squamous cell histology is ineligible). Cytologic specimens obtained by brushings, washings or needle aspiration of the defined lesion are acceptable. Sputum cytology alone is not acceptable. Mixed tumors with small cell elements are not eligible.
• Newly diagnosed unresectable stage IIIB or stage IV disease. Patients with stage IIIB disease should be ineligible for combined modality therapy (i.e., pleural effusions, pericardial effusions, etc.).
• At least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan. Measurable disease is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• Demonstration of K-ras wild type in archived tumor tissue. Tissue must be available for testing or results from previous K-ras testing must be available at the time of registration.
• No prior antineoplastic chemotherapy for metastatic lung cancer. Patients may have received adjuvant treatment for stage I, II or III disease.
• For patients who have had previous radiotherapy as definitive therapy for locally advanced NSCLC, recurrence must be outside of the original radiation therapy port. Radiation therapy must have been completed more than four weeks prior to study entry. Previous radiation must have covered \< 30% of marrow bearing area.
• Full recovery from surgery for patients who have undergone thoracotomy. Patients cannot start protocol treatment until at least three weeks after an operative procedure.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 12 weeks.
• Normal bone marrow function within 7 days prior to initial treatment as defined by:
• absolute neutrophil count (ANC) ≥1500/µL
• platelets ≥100,000/µL
• hemoglobin ≥8.0 g/dL. Patients may receive transfusions or erythropoietin to maintain or exceed this level.
• Normal hepatic function as defined by:

You may not qualify if:

• NSCLC with squamous cell histology.
• History of any invasive cancer treated within the previous 5 years with the exception of the disease under study, curatively treated non melanoma skin cancer or carcinoma in situ of the cervix.
• Prior therapy which specifically and directly targets the EGFR pathway (e.g., cetuximab, gefitinib, erlotinib, lapatinib).
• Active brain or meningeal metastases. Patients must have completed any previous radiotherapy at least four weeks prior to study entry and recovered from any toxicity associated with radiotherapy. Patients must have no on-going requirement for and must have discontinued corticosteroids.
• Pregnancy or breast-feeding.
• A serious active infection at the time of treatment or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
• Acute hepatitis or known human immunodeficiency virus (HIV) infection.
• Presence of third space fluid which is clinically significant and cannot be controlled by drainage.
• History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan).
• History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.
• Prior severe infusion reaction to a monoclonal antibody or history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study (e.g., carboplatin, pemetrexed).

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Amgen: collaborator

Study Sites (13)

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Medical Oncology Associates of Augusta

Augusta, Georgia, 30901, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Baptist Hospital East

Louisville, Kentucky, 40207, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

National Capital Clinical Research Consortium

Bethesda, Maryland, 20817, United States

Location

Portsmouth Regional Hospital

Portsmouth, New Hampshire, 03801, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Cancer Centers of Southwest Oklahoma

Lawton, Oklahoma, 73505, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Peninsula Cancer Institute

Newport News, Virginia, 23601, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Pemetrexed; Panitumumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: John D Hainsworth, MD
• Organization: Sarah Cannon Research Institute

asksarah@scresearch.net

1-877-691-7274

Study Officials

• David R Spigel, MD

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2009
• First Posted: January 5, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: May 11, 2016
• Results First Posted: April 15, 2016

Record last verified: 2016-04

Locations

US (13)