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Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Resected NSCLC
This study is currently recruiting participants.
Verified by Sarah Cannon Research Institute, February 2009
First Received: December 26, 2007   Last Updated: February 2, 2009   History of Changes
Sponsors and Collaborators: Sarah Cannon Research Institute
SCRI Oncology Research Consortium
Genentech
Sanofi-Aventis
Information provided by: Sarah Cannon Research Institute
ClinicalTrials.gov Identifier: NCT00621049
  Purpose

Multicenter randomized phase II trial is 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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Docetaxel, Carboplatin, Bevacizumab, Erlotinib
Drug: Docetaxel, Carboplatin
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Docetaxel Erlotinib hydrochloride Erlotinib Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Randomized Phase II Trial of Adjuvant Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Patients With Resected Non-Small Cell Lung Cancer

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, 2-year, and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 172
Study Start Date: December 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Docetaxel, Carboplatin, Bevacizumab and Erlotinib
Drug: Docetaxel, Carboplatin, Bevacizumab, Erlotinib

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.

B: Active Comparator
Docetaxel, Carboplatin
Drug: Docetaxel, Carboplatin

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.)
  4. No evidence of metastatic disease
  5. ANC >= 1500, platelets >= 100,000 and hemoglobin >= 10.0.
  6. Total bilirubin <= ULN. AST and ALT and alkaline phosphatase must be WNL
  7. Serum creatinine <= 1.5mg/dl (If greater than 1.5, the creatinine clearance, calculated according to the Cockroft-Gault formula, must be >= 50ml/min).
  8. Patients may have had no previous chemotherapy, radiation therapy, angiogenesis inhibitor, or tyrosine kinase inhibitor for non-small cell lung cancer.
  9. Patients must be able to understand the nature of this study and give written informed consent.
  10. Age >= 18 years
  11. Ability to start treatment between 8 and 12 weeks following surgery.
  12. Ability to take oral medication.

Exclusion Criteria:

  1. 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
  2. Mixed small cell and non-small cell histologies
  3. Pulmonary carcinoid tumors
  4. Positive bronchial margins
  5. History of prior malignancy within 5 years with the exception of skin cancer or cervical carcinoma in situ.
  6. 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.
  7. Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment.
  8. Patients with seizures not controlled with standard medical therapy.
  9. Patients with active infection requiring parenteral antibiotics
  10. 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
  11. Fine needle aspiration, core biopsy or other minor surgical procedure (excluding placement of a vascular access device) within 7 days of beginning study treatment.
  12. 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.
  13. 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).
  14. Patients with serious nonhealing wound, ulcer, or bone fracture.
  15. Patients with evidence of bleeding diathesis or coagulopathy.
  16. Patients with history of hemoptysis defined as bright red blood of ½ teaspoon or more per episode) within 8 weeks prior to study treatment.
  17. History of myocardial infarction or unstable angina within 6 months of beginning study treatment.
  18. Inadequately controlled hypertension (defined as systolic blood pressure > 150 and /or diastolic blood pressure > 100 mmHg on antihypertensive medications).
  19. New York Heart Association (NYHA) grade II or greater CHF.
  20. Serious cardiac arrhythmia requiring medication.
  21. Symptomatic peripheral vascular disease.
  22. History of stroke or transient ischemic attack within 6 months prior to beginning bevacizumab.
  23. Any prior history of hypertensive crisis or hypertensive encephalopathy.
  24. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning study treatment.
  25. ECOG Performance status > 1.
  26. Peripheral neuropathy> grade 1.
  27. Known hypersensitivity to any component of study drugs including platinum or to drugs formulated with polysorbate 80.
  28. Impaired oral absorption.
  29. Inability to comply with study and/or follow-up procedures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621049

Contacts
Contact: David Spigel, M.D. (615) 329-7274 dspigel@tnonc.com
Contact: Trials Info (615) 329-7274 trialsinfo@scresearch.net

Locations
United States, Alabama
Northeast Alabama Regional Medical Center Recruiting
Anniston, Alabama, United States, 36207
United States, Florida
Florida Cancer Specialists Recruiting
Fort Myers, Florida, United States, 33901
Contact: Katie Goodman     239-274-9930     KatieG@flcancer.com    
United States, Georgia
Wellstar Cancer Research Recruiting
Marietta, Georgia, United States, 30060
United States, Kentucky
Consultants in Blood Disorders and Cancer Recruiting
Louisville, Kentucky, United States, 40207
Contact: Judy Sisk     502-897-1166 ext 129     jsisk@cbcdocs.com    
United States, Louisiana
Hematology Oncology Life Center Recruiting
Alexandria, Louisiana, United States, 71301
Baton Rouge General Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70806
United States, Maryland
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
United States, Mississippi
Jackson Oncology Associates Recruiting
Jackson, Mississippi, United States, 39202
United States, Missouri
St. Louis Cancer Care Recruiting
Chesterfield, Missouri, United States, 63017
United States, Nebraska
Methodist Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
United States, New Jersey
Hematology Oncology Associates of Northern NJ Recruiting
Morristown, New Jersey, United States, 07960
United States, New Mexico
New Mexico Oncology Hematology Consultants Recruiting
Albuquerque, New Mexico, United States, 87109
United States, North Carolina
Cancer Care of Western North Carolina Recruiting
Asheville, North Carolina, United States, 28801
United States, Ohio
Oncology Hematology Care Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Research Program Coordinator     513-891-4800     contact@ohcmail.com    
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37023
Chattanooga Oncology Hematology Associates Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Research Coordiantor     423-698-1844     research@cohaonline.com    
Associates in Hematology Oncology Recruiting
Chattanooga, Tennessee, United States, 37404
United States, Virginia
Peninsula Cancer Institute Recruiting
Newport News, Virginia, United States, 23601
Sponsors and Collaborators
Sarah Cannon Research Institute
SCRI Oncology Research Consortium
Genentech
Sanofi-Aventis
Investigators
Study Chair: David Spigel, M.D. SCRI Oncology Research Consortium
  More Information

No publications provided

Responsible Party: SCRI Oncology Research Consortium ( David Spigel, M.D. )
Study ID Numbers: SCRI LUN 142, US_IST_12218, AVF3923s
Study First Received: December 26, 2007
Last Updated: February 2, 2009
ClinicalTrials.gov Identifier: NCT00621049     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Sarah Cannon Research Institute:
Non-Small Cell Lung Cancer
Resected
Carboplatin
Docetaxel
Bevacizumab
Erlotinib

Study placed in the following topic categories:
Thoracic Neoplasms
Erlotinib
Adjuvants, Immunologic
Bevacizumab
Carboplatin
Protein Kinase Inhibitors
Angiogenesis Inhibitors
Carcinoma
Docetaxel
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Bevacizumab
Protein Kinase Inhibitors
Docetaxel
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Growth Substances
Enzyme Inhibitors
Carboplatin
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009