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Docetaxel, Carboplatin, and Bevacizumab in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery

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.
 
ClinicalTrials.gov Identifier: NCT00293332
Recruitment Status : Terminated (Terminated due to low subject accrual)
First Posted : February 17, 2006
Last Update Posted : February 9, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE February 16, 2006
First Posted Date  ICMJE February 17, 2006
Last Update Posted Date February 9, 2011
Study Start Date  ICMJE December 2005
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2009)
Clinical response rate by CT scan after 3 courses of induction treatment [ Time Frame: After 3 cycles of induction treatment ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2009)
  • Pathologic response rate after 3 courses of induction treatment [ Time Frame: After 3 cycles of induction treatment ]
  • Resectability rate after 3 courses of induction treatment [ Time Frame: After 3 cycles of induction treatment ]
  • Median survival at 2 years after surgery [ Time Frame: 2 years after surgery ]
  • Safety after 3 courses of induction treatment [ Time Frame: After 3 cycles of induction treatment ]
  • Overall survival at 2 years after surgery [ Time Frame: 2 years after surgery ]
  • Time to treatment failure within 2 years after surgery [ Time Frame: 2 years after surgery ]
  • Correlation of serum VEGF levels prior to neoadjuvant therapy with primary and secondary objectives prior to start of induction treatment [ Time Frame: Before induction treatment ]
  • Correlation of serum VEGF expression in resected tumor with primary and secondary objectives [ Time Frame: After surgical removal of tumor ]
  • Correlation of VEGF levels measured immediately after resection and after adjuvant bevacizumab therapy with primary and secondary objectives [ Time Frame: After resection and after adjuvant bevacizumab ]
  • Assay additional downstream VEGF activation pathway markers [ Time Frame: At any time during the study ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel, Carboplatin, and Bevacizumab in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery
Official Title  ICMJE A Phase II Study of Neoadjuvant Therapy With Docetaxel, Carboplatin, and Bevacizumab in Patients With Resectable Early Stage Non-Small Cell Lung Cancer
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving docetaxel and carboplatin together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with bevacizumab works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.

Detailed Description

OBJECTIVES:

Primary

  • Determine the clinical response rate in patients with stage IB-IIIA non-small cell lung cancer treated with neoadjuvant docetaxel, carboplatin, and bevacizumab.

Secondary

  • Determine the median and overall survival of patients treated with this regimen.
  • Determine the safety profile of this regimen.
  • Determine the time to treatment failure of patients treated with this regimen.
  • Determine the pathologic response rate and the resectability rate in patients treated with this regimen.
  • Correlate vascular endothelial growth factor (VEGF) levels or expression with response and survival of patients treated with this regimen.

OUTLINE: Patients receive docetaxel IV over 15-60 minutes, carboplatin IV over 30-60 minutes, and bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Approximately 4-6 weeks after completion of chemotherapy, eligible patients with no distant or mediastinal disease progression undergo lobectomy, pneumonectomy, or segmentectomy with standard radical mediastinal lymph node dissection.

NOTE: *Bevacizumab is only administered during courses 1 and 2.

After completion of study treatment, patients are followed periodically for 8 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Biological: bevacizumab
    Neoadjuvant therapy with 15 mg/kg, IV on Day 1 of each 21 day cycle for the first 2 cycles.
    Other Name: Avastin
  • Drug: carboplatin
    Neoadjuvant therapy, AUC 6, IV on day 1 of each 21 day cycle for 3 cycles.
    Other Name: Paraplatin
  • Drug: docetaxel
    Neoadjuvant therapy, 75 mg/m2, IV on day 1 of each 21 day cycle for 3 cycles.
    Other Name: Taxotere
  • Procedure: conventional surgery
    Standard surgery after 3 cycles of neoadjuvant therapy with docetaxel, carboplatin, and bevacizumab. Bevacizumab is given for the first 2 cycles only.
    Other Name: Resection
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 5, 2009)
1
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer

    • No squamous cell carcinoma
    • No histology in close proximity to a major vessel
  • Resectable stage IB-IIIA disease
  • No CNS or brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Bilirubin normal
  • Creatinine ≤ 1.5 mg/dL
  • Urine protein:creatinine < 1.0
  • Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:

    • AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
    • AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
    • AP ≤ 5 times ULN AND AST and ALT normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment
  • Adequate pulmonary and cardiovascular function to tolerate surgical resection
  • No cavitation or history of hemoptysis (i.e., bright red blood ≥ ½ teaspoon)
  • No existing peripheral neuropathy ≥ grade 1
  • No known history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
  • No history of serious systemic disease, including any of the following:

    • Myocardial infarction within the past 6 months
    • Uncontrolled hypertension (i.e., blood pressure > 150/110 mm Hg on medication)
    • Unstable angina
    • New York Heart Association class II-IV congestive heart failure
    • Unstable symptomatic arrhythmia requiring medication

      • Patients with chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are eligible
    • Clinically significant peripheral vascular disease (i.e., grade II or higher)
  • No history of significant neurological or psychiatric condition
  • No known active infection within the past 14 days
  • No serious, nonhealing wound, ulcer, or bone fracture
  • No evidence of bleeding diathesis or coagulopathy
  • No stroke within the past 6 months
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No other serious illness or medical condition
  • No active infection
  • No other currently active malignancy except nonmelanoma skin cancer

    • Malignancies for which therapy has been completed and are considered to have ≤ 30% chance of risk of relapse are not considered active

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or VEGF inhibitor
  • No prior (i.e., within the past 4 weeks), concurrent, or anticipated participation in another experimental drug study except a Genentech-sponsored bevacizumab cancer study
  • No major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days
  • No anticipation for major surgical procedure during study treatment
  • No fine-needle aspiration or core biopsy within 7 days prior to study entry
  • No concurrent full-dose anticoagulation
  • No other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy for this cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00293332
Other Study ID Numbers  ICMJE CDR0000455640
UCSF-04652
UCSF-IIT-12198
UCSF-H5535-25047-01A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sarita Dubey, M.D., UCSF
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Sarita Dubey, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP