Status:
COMPLETED
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
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 t...
Detailed Description
In this clinical trial, we also will be studying other things. We want to learn more about how to manage side effects patients may develop during chemotherapy. Cancer patients may develop side effects...
Eligibility Criteria
Inclusion
- Pathologically confirmed Non-Small Cell Lung Cancer at MSKCC
- Clinical stage IIIB or IV.
- Measurable disease as per RECIST
- Greater than 6 months since receiving neo-adjuvant or adjuvant chemotherapy for Non-Small Cell Lung Cancer.
- Age ≥ 18 years.
- Karnofsky performance status of ≥ to 70.
- Marrow and organ function as follows:
- WBC ≥ to 4000/mm3
- Platelets ≥ to 160,000
- Bilirubin ≤ to 1.2mg/dL
- Creatinine clearance ≥ to 40mL/min
- AST and/or /ALT ≤ 37 Units/L (if one of these elevated, must be ≤ 2.5 ULN)
- Systolic blood pressure ≤ to 150mmHg or diastolic blood pressure ≤ to 100 mmHg).
- The subject is able to read and comprehend English text from a computer screen.
- Women of childbearing potential and sexually active men enrolled in the study must agree to practice effective contraception.
Exclusion
- Squamous cell carcinoma.
- Prior treatment with paclitaxel, pemetrexed or bevacizumab for NSCLC.
- Prior systemic anticancer therapy for advanced NSCLC.
- Symptomatic brain metastases with evidence of hemorrhage.
- Radiation therapy to greater than 25% of the bone marrow within 30 days of starting treatment.
- Peripheral neuropathy greater than grade 1.
- Malignancies within the past 5 years other than non-melanoma skin cancer.
- Patients with other serious medical illnesses including, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of hemoptysis.
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess.
- History of myocardial infarction or stroke within 6 months prior to enrollment.
- Pregnancy or lactation.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00807573
Start Date
December 1 2008
End Date
April 1 2014
Last Update
December 30 2015
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
4
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York, United States