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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00621049
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : May 14, 2015
Last Update Posted : June 8, 2015
Genentech, Inc.
Information provided by (Responsible Party):
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : July 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Disease-free Survival [ Time Frame: 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 :
  1. Safety [ Time Frame: 2 years ]
    Adverse Events occuring in >15% of patients

  2. 2-year Survival [ Time Frame: 24 months ]
    Proportion of patients known to still be alive 2 years after coming on study

  3. Overall Survival (OS) [ Time Frame: 18 months ]
    The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00621049

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Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Study Chair: David Spigel, M.D. SCRI Development Innovations, LLC

Responsible Party: SCRI Development Innovations, LLC Identifier: NCT00621049     History of Changes
Other Study ID Numbers: SCRI LUN 142
First Posted: February 22, 2008    Key Record Dates
Results First Posted: May 14, 2015
Last Update Posted: June 8, 2015
Last Verified: May 2015

Keywords provided by SCRI Development Innovations, LLC:
Non-Small Cell Lung Cancer

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