Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Resected NSCLC
Randomized Phase II Trial of Adjuvant Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Patients With Resected Non-Small Cell Lung Cancer
3 other identifiers
interventional
112
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Dec 2007
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
February 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
May 14, 2015
CompletedJune 8, 2015
May 1, 2015
5.6 years
December 26, 2007
April 24, 2015
May 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free Survival
The length of time, in months, that patients were alive from the end of their treatment without any signs or symptoms of their disease.
1 year
Secondary Outcomes (3)
Safety
2 years
2-year Survival
24 months
Overall Survival (OS)
18 months
Study Arms (2)
Docetaxel/Carboplatin/Bevacizumab/Erlotinib
EXPERIMENTALDocetaxel and Carboplatin
ACTIVE COMPARATORInterventions
Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1 Docetaxel should be administered before carboplatin. After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows: Maintenance Treatment for patients in Cohort A: Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity.
Adjuvant Treatment Cohort B: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Docetaxel should be administered before carboplatin. Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment.
Eligibility Criteria
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).
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Genentech, Inc.collaborator
- Sanoficollaborator
Study Sites (26)
Northeast Alabama Medical Center
Anniston, Alabama, 36207, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, 33705, United States
Medical Oncology Associates of Augusta
Augusta, Georgia, 30901, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Wellstar Cancer Research
Marietta, Georgia, 30060, United States
Providence Medical Group
Terre Haute, Indiana, 47802, United States
RHHP/Hope Cancer Center
Terre Haute, Indiana, 47802, United States
Baptist Hospital East
Louisville, Kentucky, 40207, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Hematology Oncology Life Center
Alexandria, Louisiana, 71301, United States
Hematology Oncology Clinic, LLP
Baton Rouge, Louisiana, 70806, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Jackson Oncology Associates
Jackson, Mississippi, 39202, United States
St. Louis Cancer Care
Chesterfield, Missouri, 63017, United States
Nebraska Methodist Cancer Center
Omaha, Nebraska, 68114, United States
Portsmouth Regional Hospital
Portsmouth, New Hampshire, 03801, United States
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, 07960, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109, United States
Cancer Care of Western North Carolina
Asheville, North Carolina, 28801, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Associates in Hematology Oncology
Chattanooga, Tennessee, 37404, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Peninsula Cancer Institute
Newport News, Virginia, 23601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John D Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- STUDY CHAIR
David Spigel, M.D.
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2007
First Posted
February 22, 2008
Study Start
December 1, 2007
Primary Completion
July 1, 2013
Study Completion
February 1, 2014
Last Updated
June 8, 2015
Results First Posted
May 14, 2015
Record last verified: 2015-05