Phase II Trial of Preoperative Pemetrexed and Carboplatin in Patients With Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Pemetrexed
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- SCRI Development Innovations, LLC
- Enrollment
- 46
- Locations
- 12
- Primary Endpoint
- 3-Year Overall Survival Rate
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Exclusion Criteria
- •Patients with the following stages are excluded:
- •T2 N0, with primary tumor \<4 cm;
- •T1-2 N2, with multiple zones of N2 involvement;
- •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.
Arms & Interventions
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.
Intervention: Pemetrexed
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.
Intervention: Carboplatin
Outcomes
Primary Outcomes
3-Year Overall Survival Rate
Time Frame: 36 months
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.
Secondary Outcomes
- 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)