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

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Sanofi
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00621049
First received: December 26, 2007
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Docetaxel/Carboplatin/Bevacizumab/Erlotinib
Drug: Docetaxel/Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

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 ]

Enrollment: 112
Study Start Date: December 2007
Study Completion Date: February 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel/Carboplatin/Bevacizumab/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.

Active Comparator: Docetaxel and 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621049

  Show 26 Study Locations
Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Sanofi
Investigators
Study Chair: David Spigel, M.D. SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00621049     History of Changes
Other Study ID Numbers: SCRI LUN 142, US_IST_12218, AVF3923s
Study First Received: December 26, 2007
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by SCRI Development Innovations, LLC:
Non-Small Cell Lung Cancer
Resected
Carboplatin
Docetaxel
Bevacizumab
Erlotinib

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

ClinicalTrials.gov processed this record on November 20, 2014