Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III NSCLC

Part of paid clinical trials in Fort Lauderdale, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00960297
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64
  • Paclitaxel — DRUG
    Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
  • Bevacizumab — DRUG
    Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)

Study Details

The rationale for this multicenter, phase II trial is to examine the impact of carboplatin/paclitaxel with bevacizumab in the preoperative treatment of patients with stage IB (\> 4.0 cm), II, and select stage III NSCLC. If this novel regimen proves to be safe and active in this setting, this would provide rationale for further investigation in a larger, prospective, randomized setting.

Key Dates

First listed
Aug 17, 2009
Start date
Aug 31, 2009
Status verified
Dec 2021
Primary completion
Nov 30, 2012
Completion
May 31, 2013

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Carboplatin/Paclitaxel/Bevacizumab
    Preoperative chemotherapy and bevacizumab

Primary Outcome Measure

To Assess 3-year Overall Survival in Patients With Stage IB (>4.0 cm), II, or Select Stage III NSCLC Treated With Preoperative Carboplatin, Paclitaxel, and Bevacizumab Followed by Surgical Resection. [ Time Frame: 36 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Holy Cross HospitalFort LauderdaleFlorida33308-
Providence Medical GroupTerre HauteIndiana47802-
Norton Cancer InstituteLouisvilleKentucky40207-
Grand Rapids Clinical Oncology ProgramGrand RapidsMichigan49503-
Portsmouth Regional HospitalPortsmouthNew Hampshire03801-
Tennessee OncologyNashvilleTennessee37203-

Find similar trials in Fort Lauderdale, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Holy Cross Hospital· Fort Lauderdale, FLProvidence Medical Group· Terre Haute, INNorton Cancer Institute· Louisville, KYGrand Rapids Clinical Oncology Program· Grand Rapids, MIPortsmouth Regional Hospital· Portsmouth, NHTennessee Oncology· Nashville, TN

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