Phase II Trial of Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Carboplatin
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- SCRI Development Innovations, LLC
- Enrollment
- 4
- Locations
- 6
- Primary Endpoint
- To Assess 3-year Overall Survival in Patients With Stage IB (>4.0 cm), II, or Select Stage III NSCLC Treated With Preoperative Carboplatin, Paclitaxel, and Bevacizumab Followed by Surgical Resection.
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
The rationale for this multicenter, phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (> 4.0 cm), II, and select stage III NSCLC. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.
Detailed Description
Adjuvant chemotherapy for patients with completely resected stage II and select stage III NSCLC is considered standard therapy. At least three large, prospective randomized trials have proven the benefit of adjuvant chemotherapy in improving survival in these patients (with a magnitude of benefit ranging from 4-12%). However, in patients who are not considered to be candidates for up-front complete resection, preoperative therapy may be indicated. Many of these patients will subsequently be eligible for resection (bimodality therapy). The rationale for this multicenter, Phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (\>4.0 cm), II, and select stage III NSCLC. This trial will be conducted by the Sarah Cannon Research Institute Oncology Research Consortium. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>=18 years.
- •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 RT is not planned.
- •T1-2 N2 tumors: For patients with N2 disease involving 1 zone (Upper zone (R), AP zone (L), subcarinal zone, or lower zone) and nodes \<=2 cm 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).
Exclusion Criteria
- •Mixed small-cell and non-small cell histologies.
- •Pulmonary carcinoid tumors.
- •History of prior malignancy within 3 years, with the exception of non-melanoma skin cancer or carcinoma in situ.
- •Peripheral neuropathy \>= grade
- •Patients receiving thrombolytic therapy within 10 days of starting study treatment are ineligible. Therapeutic anticoagulation is allowed if the anticoagulant dosing is stable.
- •History of acute myocardial infarction or unstable angina within 6 months prior to Day 1 of study treatment.
- •History of or stroke or ischemic attack within 6 months prior to Day 1 of study treatment.
- •Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) in spite of medical management.
- •New York Heart Association (NYHA) class II or greater congestive heart failure (CHF).
- •Patients with significant vascular disease (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of study treatment.
Arms & Interventions
Carboplatin/Paclitaxel/Bevacizumab
Preoperative chemotherapy and bevacizumab
Intervention: Carboplatin
Carboplatin/Paclitaxel/Bevacizumab
Preoperative chemotherapy and bevacizumab
Intervention: Paclitaxel
Carboplatin/Paclitaxel/Bevacizumab
Preoperative chemotherapy and bevacizumab
Intervention: Bevacizumab
Outcomes
Primary Outcomes
To Assess 3-year Overall Survival in Patients With Stage IB (>4.0 cm), II, or Select Stage III NSCLC Treated With Preoperative Carboplatin, Paclitaxel, and Bevacizumab Followed by Surgical Resection.
Time Frame: 36 months
Secondary Outcomes
- Clinical & Pathologic Response Rate(60 months)
- Number of Participants Experiencing Adverse Events as a Measure of Toxicity(45 months)
- Progression-free Survival(60 months)
- Complete Resection Rate(60 months)
- Overall Survival(60 months)