Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer
Phase II Trial of Preoperative Pemetrexed and Carboplatin in Patients With Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer
1 other identifier
interventional
46
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2009
Longer than P75 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2009
CompletedFirst Posted
Study publicly available on registry
May 21, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
February 24, 2017
CompletedFebruary 24, 2017
January 1, 2017
6.2 years
May 19, 2009
November 7, 2016
January 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-Year Overall Survival Rate
The percentage of patients who were alive at 3 years from time of first study treatment until date of death from any cause. Overall survival is shown for the Intent-to-Treat population.
36 months
Secondary Outcomes (4)
Objective Tumor Response
At 6 and 12 weeks
Pathologic Response Rate
weeks 15 -18
Rate of Residual Disease as an Assessment of Pathological Partial Response (pPR)
At 15-18 weeks
Complete Resection Rate
At weeks 15-18
Study Arms (1)
Pemetrexed/Carboplatin
EXPERIMENTAL4 cycles of preoperative treatment (1 Cycle = 21 days): Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle; Carboplatin: AUC 6.0 by IV on Day 1 each cycle.
Interventions
500 mg/m2 IV over 10 minutes on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
AUC 6.0 IV on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
Eligibility Criteria
You may qualify if:
- Histologically-confirmed NSCLC (adenocarcinoma, large cell, and undifferentiated). Patients with squamous histology are not eligible.
- Life expectancy of at least 12 weeks.
- 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.
- Patients with clinical N2 involvement must have histologic confirmation by mediastinoscopy (or alternate biopsy procedure).
- Tumors should be considered potentially resectable.
- No evidence of extrathoracic metastatic disease.
- Patients must have measurable disease by RECIST criteria.
- Patients must be candidates (medically) for chemotherapy followed by surgical resection.
- 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.
- Laboratory values as follows:
- +12 more criteria
You may not qualify if:
- 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.
- Squamous or predominant squamous mixed histologies.
- Mixed small-cell and non-small cell histologies.
- Pulmonary carcinoid tumors.
- Presence of third space fluid which cannot be controlled by drainage.
- Use of erythropoietin as a hematopoietic growth factor is not allowed.
- 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.
- Women who are pregnant (positive pregnancy test) or lactating.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Eli Lilly and Companycollaborator
Study Sites (12)
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Medical Oncology Associates of Augusta
Augusta, Georgia, 30901, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Baptist Hospital East
Louisville, Kentucky, 40207, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
National Capital Clinical Research Consortium
Bethesda, Maryland, 20817, United States
Nebraska Methodist Cancer Center
Omaha, Nebraska, 68114, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, 29210, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Virginia Cancer Institute
Richmond, Virginia, 23235, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Charles Davis, RAC
- Organization
- SCRI Development Innovations
Study Officials
- STUDY CHAIR
David R Spigel, M.D.
SCRI Development Innovations, LLC
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
May 19, 2009
First Posted
May 21, 2009
Study Start
June 1, 2009
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
February 24, 2017
Results First Posted
February 24, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share