Status:
COMPLETED
Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Becaus...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00906282
Start Date
June 1 2009
End Date
September 1 2015
Last Update
February 24 2017
Active Locations (12)
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1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
2
Medical Oncology Associates of Augusta
Augusta, Georgia, United States, 30901
3
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
4
Baptist Hospital East
Louisville, Kentucky, United States, 40207