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

NCT ID: NCT00293332

Last Updated: 2011-02-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2007-04-30

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bevacizumab

Neoadjuvant therapy with 15 mg/kg, IV on Day 1 of each 21 day cycle for the first 2 cycles.

Intervention Type: BIOLOGICAL

carboplatin

Neoadjuvant therapy, AUC 6, IV on day 1 of each 21 day cycle for 3 cycles.

Intervention Type: DRUG

docetaxel

Neoadjuvant therapy, 75 mg/m2, IV on day 1 of each 21 day cycle for 3 cycles.

Intervention Type: DRUG

conventional surgery

Standard surgery after 3 cycles of neoadjuvant therapy with docetaxel, carboplatin, and bevacizumab. Bevacizumab is given for the first 2 cycles only.

Intervention Type: PROCEDURE

Other Intervention Names

Avastin; Paraplatin; Taxotere; Resection

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

UCSF

Principal Investigators

Sarita Dubey, MD

Role: STUDY_CHAIR

University of California, San Francisco

Locations

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Countries

United States

Other Identifiers

UCSF-04652

Identifier Type: -

Identifier Source: secondary_id

UCSF-IIT-12198

Identifier Type: -

Identifier Source: secondary_id

UCSF-H5535-25047-01A

Identifier Type: -

Identifier Source: secondary_id

CDR0000455640

Identifier Type: -

Identifier Source: org_study_id