Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Resected NSCLC

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

Multicenter randomized phase II trial to examine the safety and efficacy of carboplatin, docetaxel, bevacizumab followed by maintenance bevacizumab and erlotinib in patients with completely resected stage IB, II, and select III NSCLC.

Key facts

Study ID

NCT00621049

Run by

SCRI Development Innovations, LLC

People needed

112

Starts

2007-12-01

Expected to finish

2014-02-01

Last updated by the study team

2015-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically-confirmed non-small cell lung cancer (adenocarcinoma, squamous, large cell and undifferentiated). Mixed small cell and non-small histologies are excluded.
• Patients with completely resected (R0) stage IB, II, and select III NSCLC. The following stages are eligible:
• IB T2 N0 IIA T1 N1 IIB T2 N1 IIB T3 N0 IIIA T3 N1
• Bronchioalveolar carcinoma that presents as a single, solitary discrete nodule or mass may be included
• Patients determined to have N2 disease, that was not apparent radiologically preoperatively (and completely resected) can be included.
• Complete surgical resection defined as the appropriate pulmonary parenchymal resection including lobectomy, bilobectomy, sleeve lobectomy, and pneumonectomy with histologically confirmed negative bronchial margins. Patients treated by segmentectomy or wedge resection are not eligible for this study. Additionally all patients must have had either a mediastinal node dissection or at least, sampling of 2 mediastinal nodal stations (levels 4,7,and 9 for right-sided tumors, and levels 5,6,7, and 9 for left-sided tumors are suggested.)
• No evidence of metastatic disease
• ANC >= 1500, platelets >= 100,000 and hemoglobin >= 10.0.
• Total bilirubin <= ULN. AST and ALT and alkaline phosphatase must be WNL
• Serum creatinine <= 1.5mg/dl (If greater than 1.5, the creatinine clearance, calculated according to the Cockroft-Gault formula, must be >= 50ml/min).
• Patients may have had no previous chemotherapy, radiation therapy, angiogenesis inhibitor, or tyrosine kinase inhibitor for non-small cell lung cancer.
• Patients must be able to understand the nature of this study and give written informed consent.
• Age >= 18 years
• Ability to start treatment between 8 and 12 weeks following surgery.
• Ability to take oral medication.

You may not qualify if…

• Patients with preoperative radiologic evidence of N2 disease by either PET or CT scan (i.e. radiological evidence of metastasis to ipsilateral mediastinal and subcarinal nodes) that is confirmed as N2 disease histologically are excluded. - PLEASE SEE EXCEPTION in section 3.1.2 of protocol
• Mixed small cell and non-small cell histologies
• Pulmonary carcinoid tumors
• Positive bronchial margins
• History of prior malignancy within 5 years with the exception of skin cancer or cervical carcinoma in situ.
• Women who are pregnant (positive pregnancy test) or breast-feeding. Subjects of childbearing potential or with partners of childbearing potential (women and men) must use effective birth control measures during treatment.
• Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment.
• Patients with seizures not controlled with standard medical therapy.
• Patients with active infection requiring parenteral antibiotics
• Patients who have had major surgical procedure, open biopsy, or significant traumatic injury within 8 weeks of beginning study treatment or anticipation of need for major surgical procedure during the course of the study
• Fine needle aspiration, core biopsy or other minor surgical procedure (excluding placement of a vascular access device) within 7 days of beginning study treatment.
• Patients receiving thrombolytic therapy within 10 days of starting study treatment are also ineligible. Patients may receive prophylactic anticoagulation therapy, 1 mg coumadin daily for port clot prophylaxis.
• Patients with proteinuria at screening as demonstrated by either:
• Urine protein creatinine (UPC) ratio >= 1.0 at screening OR
• Urine dipstick for proteinuria >= 2+ (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate >= 1 g of protein in 24hours to be eligible).
• Patients with serious nonhealing wound, ulcer, or bone fracture.
• Patients with evidence of bleeding diathesis or coagulopathy.
• Patients with history of hemoptysis defined as bright red blood of ½ teaspoon or more per episode) within 8 weeks prior to study treatment.
• History of myocardial infarction or unstable angina within 6 months of beginning study treatment.
• Inadequately controlled hypertension (defined as systolic blood pressure > 150 and /or diastolic blood pressure > 100 mmHg on antihypertensive medications).
• New York Heart Association (NYHA) grade II or greater CHF.
• Serious cardiac arrhythmia requiring medication.
• Symptomatic peripheral vascular disease.
• History of stroke or transient ischemic attack within 6 months prior to beginning bevacizumab.
• Any prior history of hypertensive crisis or hypertensive encephalopathy.

Where it is running

• Northeast Alabama Medical Center — Anniston, Alabama, United States
• Northeast Arkansas Clinic — Jonesboro, Arkansas, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Gulfcoast Oncology Associates — St. Petersburg, Florida, United States
• Medical Oncology Associates of Augusta — Augusta, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Wellstar Cancer Research — Marietta, Georgia, United States
• Providence Medical Group — Terre Haute, Indiana, United States
• RHHP/Hope Cancer Center — Terre Haute, Indiana, United States
• Baptist Hospital East — Louisville, Kentucky, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Hematology Oncology Life Center — Alexandria, Louisiana, United States
• Hematology Oncology Clinic, LLP — Baton Rouge, Louisiana, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Jackson Oncology Associates — Jackson, Mississippi, United States
• St. Louis Cancer Care — Chesterfield, Missouri, United States
• Nebraska Methodist Cancer Center — Omaha, Nebraska, United States
• Portsmouth Regional Hospital — Portsmouth, New Hampshire, United States
• Hematology Oncology Associates of Northern NJ — Morristown, New Jersey, United States
• New Mexico Oncology Hematology Consultants — Albuquerque, New Mexico, United States
• Cancer Care of Western North Carolina — Asheville, North Carolina, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Associates in Hematology Oncology — Chattanooga, Tennessee, United States
• Chattanooga Oncology Hematology Associates — Chattanooga, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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