Carboplatin, Pemetrexed Disodium, and Bevacizumab in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Checked against the public recordLast updated Jun 4, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Northwestern University
- Interventions being studied
- Biological: bevacizumab; Drug: carboplatin; Drug: pemetrexed
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
DISEASE CHARACTERISTICS: * Histologically\* or cytologically\* confirmed non-small cell lung cancer * Any histology, except squamous cell carcinoma, allowed * Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible * No histology in close proximity to a major vessel or cavitation NOTE: \*Histologic or cytologic elements may be established on metastatic tumor aspirates or biopsy * Meets 1 of the following stage criteria: * Stage IIIB disease (with malignant pleural effusion) * Stage IV disease * Recurrent disease * Measurable or non-measurable disease * No known CNS metastases by CT scan or MRI PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * No history of hemorrhagic disorders Hepatic * Bilirubin \< 1.5 mg/dL * AST and ALT \< 5 times upper limit of normal * INR \< 1.5 * PTT normal Renal * Creatinine clearance ≥ 45 mL/min * Urine protein:creatinine ≤ 1.0 by spot urinalysis Cardiovascular * No myocardial infarction within the past 6 months * No New York Heart Association class II-IV congestive heart failure * No unstable angina pectoris * No serious cardiac arrhythmia requiring medication * No stroke within the past 6 months * No peripheral vascular disease ≥ grade 2 * No uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg) * Patients with a history of hypertension allowed provided blood pressure is well controlled on a stable regimen of anti-hypertensive therapy * No history of thrombotic disorders * No other clinically significant cardiovascular disease Pulmonary * No history of gross hemoptysis, defined as bright red blood of a ½ teaspoon or more Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must be willing and able to take daily oral folic acid, intermittent vitamin B\_12 injections, and corticosteroid premedication * No ongoing or active infection * No serious, non-healing wound, ulcer, or bone fracture * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * More than 3 weeks since prior immunotherapy Chemotherapy * No prior systemic chemotherapy Endocrine therapy * More than 3 weeks since prior hormonal therapy Radiotherapy * See Disease Characteristics * More than 3 weeks since prior radiotherapy Surgery * More than 4 weeks since prior major surgery * More than 1 week since prior minor surgery, fine needle aspiration, or core biopsy * No concurrent major surgery Other * Recovered from all prior therapy * More than 4 weeks since prior and no concurrent participation in another experimental drug study * No aspirin or other nonsteroidal anti-inflammatory drug (NSAID) 2 days before and 2 days after each pemetrexed disodium infusion (5 days before and 2 days after each pemetrexed disodium infusion for NSAIDs with a long half-life \[e.g., naproxen, rofecoxib, or celecoxib\]) * No concurrent therapeutic anticoagulation * Concurrent prophylactic anticoagulation for venous access devices allowed provided requirements for INR and PTT are met * No concurrent administration of any of the following: * Chronic daily treatment with aspirin (\> 325 mg per day) * NSAIDs known to inhibit platelet function, including any of the following: * Dipyridamole * Ticlopidine * Clopidogrel * Cilostazol
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois
- Rush Cancer Institute at Rush University Medical CenterChicago, Illinois
- Evanston Northwestern Healthcare - Evanston HospitalEvanston, Illinois
- Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois
- Advocate Lutheran General Cancer Care CenterPark Ridge, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 4, 2019. Always confirm current availability with the study team.