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

NCT ID: NCT01042288

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2015-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carboplatin/Pemetrexed/Panitumumab

Systemic Therapy

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

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

Pemetrexed

Intervention Type: DRUG

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

Panitumumab

Intervention Type: DRUG

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

Interventions

Carboplatin

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

Intervention Type: DRUG

Pemetrexed

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

Intervention Type: DRUG

Panitumumab

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

Intervention Type: DRUG

Other Intervention Names

Alimta; Vectibix

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years.

2. 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.

3. 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.).

4. 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.

5. 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.

6. No prior antineoplastic chemotherapy for metastatic lung cancer. Patients may have received adjuvant treatment for stage I, II or III disease.

7. 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.

8. Full recovery from surgery for patients who have undergone thoracotomy. Patients cannot start protocol treatment until at least three weeks after an operative procedure.

9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

10. Life expectancy ≥ 12 weeks.

11. 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.

12. Normal hepatic function as defined by:

• bilirubin ≤1.5 x institutional upper limit of normal (ULN).
• transaminases ≤2.5 x institutional ULN. In the presence of known hepatic metastases, transaminases may be ≤5 x institutional ULN.

13. Normal renal function within 7 days prior to initial treatment as defined by:

• serum creatinine <2.0 mg/dL
• estimated creatinine clearance (CrCl) ≥ 45 mL/min calculated by the Cockcroft-Gault method.

14. Normal metabolic function as follows:

• Magnesium ≥ institutional lower limit of normal (LLN)

15. The ability to take folic acid, vitamin B12, and dexamethasone according to the protocol.

16. The ability to interrupt non-steroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.

17. Negative serum or urine pregnancy test within 7 days prior to initial study treatment.

18. Agreement of women of child-bearing potential (WOCBP) and men to use adequate contraception (hormonal or barrier method of birth control; abstinence) to prevent contraception during treatment and for a minimum of 6 months after the last study treatment.

19. Willingness and ability to comply with study and follow-up procedures.

20. Ability to understand the nature of this study and give written informed consent.

Exclusion Criteria

1. NSCLC with squamous cell histology.

2. 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.

3. Prior therapy which specifically and directly targets the EGFR pathway (e.g., cetuximab, gefitinib, erlotinib, lapatinib).

4. 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.

5. Pregnancy or breast-feeding.

6. 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.

7. Acute hepatitis or known human immunodeficiency virus (HIV) infection.

8. Presence of third space fluid which is clinically significant and cannot be controlled by drainage.

9. History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan).

10. 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.

11. 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David R Spigel, MD

Role: STUDY_CHAIR

SCRI Development Innovations, LLC

Locations

Florida Cancer Specialists

Fort Myers, Florida, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Medical Oncology Associates of Augusta

Augusta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Baptist Hospital East

Louisville, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

National Capital Clinical Research Consortium

Bethesda, Maryland, United States

Portsmouth Regional Hospital

Portsmouth, New Hampshire, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Cancer Centers of Southwest Oklahoma

Lawton, Oklahoma, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Peninsula Cancer Institute

Newport News, Virginia, United States

Countries

United States

Other Identifiers

SCRI LUN 183

Identifier Type: -

Identifier Source: org_study_id