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

This study has been terminated.
(Terminated due to low subject accrual)
Sponsor:
Collaborator:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00293332
First received: February 16, 2006
Last updated: February 8, 2011
Last verified: June 2007
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: bevacizumab
Drug: carboplatin
Drug: docetaxel
Procedure: conventional surgery
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant Therapy With Docetaxel, Carboplatin, and Bevacizumab in Patients With Resectable Early Stage Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Clinical response rate by CT scan after 3 courses of induction treatment [ Time Frame: After 3 cycles of induction treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pathologic response rate after 3 courses of induction treatment [ Time Frame: After 3 cycles of induction treatment ] [ Designated as safety issue: No ]
  • Resectability rate after 3 courses of induction treatment [ Time Frame: After 3 cycles of induction treatment ] [ Designated as safety issue: No ]
  • Median survival at 2 years after surgery [ Time Frame: 2 years after surgery ] [ Designated as safety issue: No ]
  • Safety after 3 courses of induction treatment [ Time Frame: After 3 cycles of induction treatment ] [ Designated as safety issue: Yes ]
  • Overall survival at 2 years after surgery [ Time Frame: 2 years after surgery ] [ Designated as safety issue: No ]
  • Time to treatment failure within 2 years after surgery [ Time Frame: 2 years after surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Correlation of serum VEGF expression in resected tumor with primary and secondary objectives [ Time Frame: After surgical removal of tumor ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Assay additional downstream VEGF activation pathway markers [ Time Frame: At any time during the study ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: December 2005
Study Completion Date: April 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293332

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Chair: Sarita Dubey, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Sarita Dubey, M.D., UCSF
ClinicalTrials.gov Identifier: NCT00293332     History of Changes
Other Study ID Numbers: CDR0000455640, UCSF-04652, UCSF-IIT-12198, UCSF-H5535-25047-01A
Study First Received: February 16, 2006
Last Updated: February 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Bevacizumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014