Paclitaxel, Bevacizumab and Pemetrexed in Patients With Untreated, Advanced Non-Small Cell Lung Cancer Using Web-Based Data Collection, Patient Self-Reporting of Adverse Effects and Automated Response Assessment

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00807573
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Paclitaxel — DRUG
    Day 1: Paclitaxel (90 mg/m\^2 over 60 minutes) Day 15: Paclitaxel (90 mg/m\^2 over 60 minutes)
  • Pemetrexed — DRUG
    Day 1: Pemetrexed (500 mg/m\^2 over 10 minutes) Day 15 Pemetrexed (500 mg/m2 over 10 minutes)
  • Bevacizumab — DRUG
    Day 1:Bevacizumab (10 mg/kg over 20 minutes) Day 15: Bevacizumab (10 mg/kg over 20 minutes)

Study Details

The purpose of this study is to determine the percentage of patients with non-small cell lung cancer that will experience a shrinkage of their tumors following treatment with three medications given together: paclitaxel, pemetrexed (Alimta®), and bevacizumab (Avastin®). Each of these medications has been approved by the FDA for patients that have not received any treatment for their lung cancer. This study is designed to study the effects of all three drugs given at the same time. Each of these medications has been studied in lung cancer and is commercially available. Paclitaxel and pemetrexed are traditional chemotherapy drugs. Bevacizumab is a monoclonal antibody, which means that it attaches to a specific target. Bevacizumab attaches to a protein in the blood stream called Vascular Endothelial GrowthFactor (VEGF). VEGF helps tumors grow new blood vessels to feed themselves, and bevacizumab is thought to help block this new growth of blood vessels and starve the tumors of the nutrients they need.

Key Dates

First listed
Dec 12, 2008
Start date
Dec 31, 2008
Status verified
Nov 2015
Primary completion
Apr 30, 2014
Completion
Apr 30, 2014

Study Design

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

Arms

  • Experimental: Paclitaxel, Bevacizumab & Pemetrexed
    During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m\^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m\^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15

Primary Outcome Measure

Objective Response Rate (CR + PR by RECIST) Paclitaxel, Pemetrexed, and Bevacizumab in Patients With Advanced Non-Small Lung Cancer Who Have Received no Prior Treatment for Metastatic Disease. [ Time Frame: 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering at Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan-Kettering Cancer Center @ SuffolkCommackNew York11725-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan-Kettering at Mercy Medical CenterRockville CentreNew York--
Memoral Sloan Kettering Cancer Center@Phelps Memorial HospitalSleepy HollowNew York--

Find similar trials in Basking Ridge, NJ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Memorial Sloan-Kettering at Basking Ridge· Basking Ridge, NJMemorial Sloan-Kettering Cancer Center @ Suffolk· Commack, NYMemorial Sloan-Kettering Cancer Center· New York, NYMemorial Sloan-Kettering at Mercy Medical Center· Rockville Centre, NYMemoral Sloan Kettering Cancer Center@Phelps Memorial Hospital· Sleepy Hollow, NY

Related Studies