- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00906282
Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer
January 5, 2017 updated by: SCRI Development Innovations, LLC
Phase II Trial of Preoperative Pemetrexed and Carboplatin in Patients With Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Fort Myers, Florida, United States, 33901
- Florida Cancer Specialists
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Georgia
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Augusta, Georgia, United States, 30901
- Medical Oncology Associates of Augusta
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Gainesville, Georgia, United States, 30501
- Northeast Georgia Medical Center
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Kentucky
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Louisville, Kentucky, United States, 40207
- Baptist Hospital East
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Maryland
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Bethesda, Maryland, United States, 20817
- Center for Cancer and Blood Disorders
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Bethesda, Maryland, United States, 20817
- National Capital Clinical Research Consortium
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Nebraska
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Omaha, Nebraska, United States, 68114
- Nebraska Methodist Cancer Center
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Ohio
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Cincinnati, Ohio, United States, 45242
- Oncology Hematology Care
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South Carolina
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Columbia, South Carolina, United States, 29210
- South Carolina Oncology Associates, PA
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Oncology Hematology Associates
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Nashville, Tennessee, United States, 37023
- Tennessee Oncology, PLLC
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Virginia
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Richmond, Virginia, United States, 23235
- Virginia Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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:
- 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
- ECOG Performance Status grade 0 or 1.
- The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta.
- The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
- 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.
- Patient must be accessible for treatment and follow-up.
- Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
Exclusion Criteria:
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.
- Use of any non-approved or investigational agent within 30 days of administration of the first dose of study drug.
- Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
- 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.
- Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- History of hypersensitivity to active or inactive excipients of any component of treatment.
- Inability to comply with study and/or follow-up procedures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Pemetrexed/Carboplatin
4 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. |
500 mg/m2 IV over 10 minutes on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
Other Names:
AUC 6.0 IV on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-Year Overall Survival Rate
Time Frame: 36 months
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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.
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36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Tumor Response
Time Frame: At 6 and 12 weeks
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Objective Tumor Response defined as the percent of patients who completed up to 4 cycles of pre-operative chemotherapy and achieved a complete response (CR) or partial response (PR) assessed by Response Evaluation in Solid Tumors (RECIST) 1.0.
Patients with stable disease (SD) or response to treatment were deemed surgical candidates.
[CR=disappearance of all target tumors; PR= ≥30% decrease in the sum of the longest diameters of target tumors.
SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.]
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At 6 and 12 weeks
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Pathologic Response Rate
Time Frame: weeks 15 -18
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Percent of patients having a pathological complete or partial response (pCR or pPR) at surgery.
pCR defined as complete removal of all tumor.
pPR defined as residual viable tumor demonstrated in the resected specimen.
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weeks 15 -18
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Rate of Residual Disease as an Assessment of Pathological Partial Response (pPR)
Time Frame: At 15-18 weeks
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pPR was further assessed by the amount of residual tumor measured at surgery: microscopic residual disease = less than 1 centimeter (<1 cm); macroscopic residual disease = 1 centimeter or greater (≥1 cm).
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At 15-18 weeks
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Complete Resection Rate
Time Frame: At weeks 15-18
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The percent of patients who had surgical resection listed by procedure type: lobectomy or pneumonectomy, or resection of adjacent chest wall or mediastinal structures when appropriate.
Surgery followed standard guidelines for resection of non-small-cell lung cancer (NSCLC).
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At weeks 15-18
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: David R Spigel, M.D., SCRI Development Innovations, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
May 19, 2009
First Submitted That Met QC Criteria
May 20, 2009
First Posted (Estimate)
May 21, 2009
Study Record Updates
Last Update Posted (Actual)
February 24, 2017
Last Update Submitted That Met QC Criteria
January 5, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Carboplatin
- Pemetrexed
Other Study ID Numbers
- SCRI LUN 186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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