Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00906282
First received: May 19, 2009
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

The purpose of this multi-center Phase II trial is to examine the impact of pemetrexed/carboplatin in the preoperative treatment of patients with select stage IB, II,and III non-squamous NSCLC. Because patients with non-squamous type NSCLC have been shown to have better survival rates than patients with squamous tumors when given pemetrexed with a platinum agent, only patients with non-squamous NSCLC (adenocarcinoma, large cell, and undifferentiated), not including squamous histology, will be allowed to participate in this study. If this novel regimen proves to be safe and active in this setting, it will provide rationale for further investigation in a larger, prospective, randomized trial.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Pemetrexed
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Preoperative Pemetrexed and Carboplatin in Patients With Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • To determine the overall survival rate at 3 years. [ Time Frame: 54 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the objective tumor response. [ Time Frame: 54 months ] [ Designated as safety issue: No ]
  • To determine the pathologic tumor response rate (complete/partial) in patients with potentially resectable stage IB, II, and III non-squamous non-small-cell lung cancer receiving preoperative (neoadjuvant) therapy. [ Time Frame: 54 months ] [ Designated as safety issue: No ]
  • To determine the complete resection rate. [ Time Frame: 54 months ] [ Designated as safety issue: No ]
  • To assess post-surgical morbidity/mortality. [ Time Frame: 54 months ] [ Designated as safety issue: No ]
  • To assess progression-free survival (PFS). [ Time Frame: 54 months ] [ Designated as safety issue: No ]
  • To assess overall survival. [ Time Frame: 54 months ] [ Designated as safety issue: No ]
  • To identify predictive factors of overall survival and PFS. [ Time Frame: 54 months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: June 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed/Carboplatin

4 cycles of preoperative treatment as follows:

Pemetrexed: 500 mg/m2 given intravenously (IV) over 10 minutes on Day 1 of every 21-day treatment cycle

Carboplatin: AUC=6 given IV on Day 1 of every 21-day treatment cycle

Drug: Pemetrexed
500 mg/m2 IV over 10 minutes on Day 1 of every 3-week (21-day) treatment cycle for a total of 4 cycles (12 weeks).
Other Name: Alimta
Drug: Carboplatin
AUC=6 IV on Day 1 of every 3-week (21-day) treatment cycle for a total of 4 cycles (12 weeks).
Other Name: 41575-94-4

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >=18 years.
  2. Histologically-confirmed NSCLC (adenocarcinoma, large cell, and undifferentiated). Patients with squamous histology are not eligible.
  3. Life expectancy of at least 12 weeks.
  4. Patients with the following stages of NSCLC:

    • T2 N0 tumors: Limited to tumors >=4 cm.
    • T1-2 N1 tumors.
    • T3 N0-1 tumors (excluding superior sulcus tumors): Including tumors involving the chest wall, proximal airway, or mediastinal pleura where preoperative radiotherapy is not planned.
    • T1-2 N2 tumors: For patients with N2 disease involving one zone (Upper zone (R), AP zone (L), subcarinal zone, or lower zone) and nodes <=2cm in diameter.
    • T4 N0-1 tumors (excluding superior sulcus tumors): T4 lesions other than malignant effusions where radiotherapy is not planned.
  5. Patients with clinical N2 involvement must have histologic confirmation by mediastinoscopy (or alternate biopsy procedure).
  6. Tumors should be considered potentially resectable.
  7. No evidence of extrathoracic metastatic disease.
  8. Patients must have measurable disease by RECIST criteria.
  9. Patients must be candidates (medically) for chemotherapy followed by surgical resection.
  10. Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery; at least 3 weeks must have elapsed from the time of a major surgery.
  11. Laboratory values as follows:

    • Absolute neutrophil count (ANC) >=1500/μL
    • Hemoglobin (Hgb) >=10 g/dL
    • Platelets >=100,000/uL
    • AST/SGOT and ALT/SGPT within normal limits (WNL)
    • Total bilirubin within normal limits (WNL)
    • Calculated creatinine clearance >=45 mL/min
  12. ECOG Performance Status grade 0 or 1.
  13. The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta.
  14. The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
  15. Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  16. Patient must be accessible for treatment and follow-up.
  17. Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.

Exclusion Criteria:

  1. Patients with the following stages are excluded:

    • T1 N0;
    • T2 N0, with primary tumor <4 cm;
    • T1-2 N2, with multiple zones of N2 involvement;
    • T3-4 N2;
    • Any N3;
    • Any TxNxM1 disease; or
    • Any stage where surgery and/or chemoradiotherapy is the preferred initial approach in management, as deemed by the treating physician.
  2. Squamous or predominant squamous mixed histologies.
  3. Mixed small-cell and non-small cell histologies.
  4. Pulmonary carcinoid tumors.
  5. Presence of third space fluid which cannot be controlled by drainage.
  6. Use of erythropoietin as a hematopoietic growth factor is not allowed.
  7. Cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  8. Women who are pregnant (positive pregnancy test) or lactating.
  9. Use of any non-approved or investigational agent within 30 days of administration of the first dose of study drug.
  10. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
  11. Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  12. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
  13. History of hypersensitivity to active or inactive excipients of any component of treatment.
  14. Inability to comply with study and/or follow-up procedures.
  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: NCT00906282

Locations
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
United States, Georgia
Medical Oncology Associates of Augusta
Augusta, Georgia, United States, 30901
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Kentucky
Baptist Hospital East
Louisville, Kentucky, United States, 40207
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
National Capital Clinical Research Consortium
Bethesda, Maryland, United States, 20817
United States, Nebraska
Nebraska Methodist Cancer Center
Omaha, Nebraska, United States, 68114
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, South Carolina
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23235
Sponsors and Collaborators
SCRI Development Innovations, LLC
Eli Lilly and Company
Investigators
Study Chair: David R Spigel, M.D. SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00906282     History of Changes
Other Study ID Numbers: SCRI LUN 186
Study First Received: May 19, 2009
Last Updated: December 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
neoadjuvant NSCLC
NSCLC

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
Pemetrexed
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on October 16, 2014