A Study of Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Hoosier Cancer Research Network
Study ID
NCT00317200
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Paclitaxel — DRUG
    Paclitaxel 90 mg/m2 IV infusion over 1 hour, days 1, 8 and 15 of 28 day cycle.
  • Bevacizumab — DRUG
    Bevacizumab 10 mg/kg, days 1 and 15 of 28 day cycle

Study Details

Improvements in therapy for relapsed SCLC are much needed. Paclitaxel has been previously tested and found to have significant single agent activity in relapsed SCLC, including in refractory patients. Angiogenesis plays an important role in SCLC, increased VEGF levels are associated with worse outcomes. Bevacizumab, a monoclonal antibody to VEGF, increase response rates and survival when combined with chemotherapy agents compared with the chemotherapy agent alone in NSCLC, breast cancer, and colorectal cancer. Paclitaxel plus bevacizumab, in the dose and schedule proposed in this study, improves response rates and progression free survival compared with paclitaxel alone in women with metastatic breast cancer. Therefore, we will be testing the safety, feasibility, and efficacy of this regimen in patients with chemosensitive relapsed SCLC.

Key Dates

First listed
Apr 24, 2006
Start date
Apr 30, 2006
Status verified
Apr 2011
Primary completion
Nov 30, 2007
Completion
Nov 30, 2007

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Paclitaxel + Devacizumab in patients with chemosensitive relapsed small cell lung cancer.

Primary Outcome Measure

To determine progression free survival(PFS) of this regimen in patients with chemosensitive relapsed small cell lung cancer (SCLC). [ Time Frame: 18 months ]

Locations (17)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupSpringdaleArkansas72764-
Medical & Surgical Specialists, LLCGalesburgIllinois61401-
Cancer Care Center of Southern IndianaBloomingtonIndiana47403-
Oncology Hematology Associates of SW IndianaEvansvilleIndiana47714-
Fort Wayne Oncology & Hematology, IncFort WayneIndiana46815-
Center for Cancer Care at Goshen Health SystemGoshenIndiana46527-
Community Regional Cancer CenterIndianapolisIndiana46256-
Indiana University Cancer CenterIndianapolisIndiana46202-
Quality Cancer Center (MCGOP)IndianapolisIndiana46202-
Arnett Cancer CareLafayetteIndiana47904-
Medical Consultants, P.C.MuncieIndiana47303-
Center for Cancer Care, Inc., P.C.New AlbanyIndiana47150-
Northern Indiana Cancer Research ConsortiumSouth BendIndiana46601-
Siteman Cancer CenterSt LouisMissouri63110-
Methodist Cancer CenterOmahaNebraska68114-
Pennsylvania Oncology-Hematology AssociatesPhiladelphiaPennsylvania19106-
Fox Chase Cancer Center Extramural Research ProgramRockledgePennsylvania19046-

Find similar trials in Springdale, AR

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Highlands Oncology Group· Springdale, ARMedical & Surgical Specialists, LLC· Galesburg, ILCancer Care Center of Southern Indiana· Bloomington, INOncology Hematology Associates of SW Indiana· Evansville, INFort Wayne Oncology & Hematology, Inc· Fort Wayne, INCenter for Cancer Care at Goshen Health System· Goshen, IN

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