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

Phase 2

Completed

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Docetaxel/Carboplatin
Drug: Docetaxel/Carboplatin/Bevacizumab/Erlotinib

Registration Number: NCT00621049

Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 112

Inclusion Criteria

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.

Exclusion Criteria

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.
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning study treatment.
ECOG Performance status > 1.
Peripheral neuropathy> grade 1.
Known hypersensitivity to any component of study drugs including platinum or to drugs formulated with polysorbate 80.
Impaired oral absorption.
Inability to comply with study and/or follow-up procedures.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel and Carboplatin	Docetaxel/Carboplatin	-
Docetaxel/Carboplatin/Bevacizumab/Erlotinib	Docetaxel/Carboplatin/Bevacizumab/Erlotinib	-

Primary Outcome Measures

Name	Time	Method
Disease-free Survival	1 year	The length of time, in months, that patients were alive from the end of their treatment without any signs or symptoms of their disease.

Secondary Outcome Measures

Name	Time	Method
Safety	2 years	Adverse Events occuring in \>15% of patients
2-year Survival	24 months	Proportion of patients known to still be alive 2 years after coming on study
Overall Survival (OS)	18 months	The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

Trial Locations

Locations (26): Associates in Hematology Oncology
🇺🇸
Chattanooga, Tennessee, United States
Northeast Arkansas Clinic
🇺🇸
Jonesboro, Arkansas, United States
Tennessee Oncology, PLLC
🇺🇸
Nashville, Tennessee, United States
Northeast Alabama Medical Center
🇺🇸
Anniston, Alabama, United States
Florida Cancer Specialists
🇺🇸
Fort Myers, 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
Hematology Oncology Life Center
🇺🇸
Alexandria, Louisiana, United States
Hematology Oncology Clinic, LLP
🇺🇸
Baton Rouge, Louisiana, 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
Oncology Hematology Care
🇺🇸
Cincinnati, Ohio, United States
Chattanooga Oncology Hematology Associates
🇺🇸
Chattanooga, Tennessee, United States
Peninsula Cancer Institute
🇺🇸
Newport News, Virginia, United States
Center for Cancer and Blood Disorders
🇺🇸
Bethesda, Maryland, United States
Cancer Care of Western North Carolina
🇺🇸
Asheville, North Carolina, United States
RHHP/Hope Cancer Center
🇺🇸
Terre Haute, Indiana, United States
Gulfcoast Oncology Associates
🇺🇸
St. Petersburg, Florida, United States
Baptist Hospital East
🇺🇸
Louisville, Kentucky, United States
Norton Cancer Institute
🇺🇸
Louisville, Kentucky, United States