A Phase II Trial of 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
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase II Trial of 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
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 during treatment, such as nausea, pain, fatigue, diarrhea,
constipation, or shortness of breath. These symptoms may be due to the cancer itself, or due
to treatments like chemotherapy drugs or radiation therapy. Doctors and nurses often ask
patients about their symptoms, because an important part of cancer treatment is to make
patients feel as well as possible. If patients do not feel well, we may need to change the
way we are treating them or prescribe therapies that will decrease their symptoms. The best
way to find out how the patient is feeling is to ask them directly.
We are interested in developing new ways to ask patients about how they are feeling, using
the Internet. A special new website called STAR ("Symptom Tracking and Reporting for
Patients") has been developed to help patients record this information, so that their
doctors and nurses can review it during clinic appointments. This study is designed to help
us see if STAR is a helpful way for us to keep track of information about patients' symptoms
and quality of life.
As part of this study, a computerized (automated) technique of determining the size of the
patients tumor(s) before and after treatment will be used. This has been tested in the past
and found to be more accurate. The automated technique of determining tumor size will be
used with the routine CT scans that the patient will have as part of the study. This
automated method of measuring the tumor(s) will allow us to know sooner whether this drug
treatment is causing the disease to shrink.
The information from STAR and the automated tumor measurements are going to be placed on a
very secure Internet site. This will provide the doctor with all of the information needed
to determine if this drug combination is working for the patient and whether to continue
this study.
Also, if there is a tumor sample from a biopsy done in the past, it will be analyzed for a
protein that may be present in the lung cancer.
Inclusion Criteria:
- Pathologically confirmed NSCLC at MSKCC
- Clinical stage IIIB or IV.
- Measurable disease as per RECIST
- Greater than 6 months since receiving neo-adjuvant or adjuvant chemotherapy for
NSCLC.
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the objective response rate (CR + PR by RECIST) for the combination of paclitaxel, pemetrexed, and bevacizumab in patients with advanced NSCLC who have received no prior treatment for metastatic disease.
Outcome Time Frame:
conclusion of study
Safety Issue:
No
Principal Investigator
Maria Pietanza, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
08-109
NCT ID:
NCT00807573
Start Date:
December 2008
Completion Date:
December 2013
Related Keywords:
- Lung Cancer
- BEVACIZUMAB (AVASTIN)
- PEMETREXED (ALTIMA)
- TAXOL (PACLITAXEL)
- 08-109
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Memorial Sloan-Kettering at Basking Ridge | Basking Ridge, New Jersey 07920 |
| Memorial Sloan-Kettering Cancer Center @ Suffolk | Commack, New York 11725 |
| Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital | Sleepy Hollow, New York |
| Memorial Sloan-Kettering at Mercy Medical Center | Rockville Centre, New York |
