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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: Paclitaxel, pemetrexed and bevacizumab and Toxicity symptoms will be collected using the STAR system	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Lung Cancer Nuclear Scans

Drug Information available for: Paclitaxel Pemetrexed Pemetrexed disodium Bevacizumab

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Collecting patient-reported outcomes (toxicity-related symptoms) using wireless touchscreen laptop computers in the outpatient clinics via the MSKCC STAR system, with storage of this information in the institutional database, CRDB. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Using an automated response assessment algorithm to determine unidimensional (RECIST) measurements of lesions. Measurements will be determined in real-time and response data will be automatically downloaded into the institutional database, CRDB. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Collecting clinician-generated data using a web-based portal, StudyTracker, that automatically downloads information into the institutional data base, CRDB. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of the combination of paclitaxel, pemetrexed and bevacizumab given according to the dosing schedule outlined where both pemetrexed and bevacizumab are given biweekly. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
To assess progression-free survival. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
To assess median, one- and two-year survival. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
To evaluate the extent to which clinicians will concur with patient self-reported CTCAE symptom and toxicity information. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
To correlate ERCC1 (excision repair cross-complementation group-1) tumor expression measured by immunohistochemistry with response to treatment. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of the combination of pemetrexed and bevacizumab given biweekly during maintenance treatment. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	44
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Paclitaxel, Bevacizumab & Pemetrexed Patients will be treated as follows: albumin-bound paclitaxel 125 mg/m2 over 120 minutes (days 1, 8, and 15), bevacizumab 10 mg/kg over 20 minutes (days 1 and 15), pemetrexed 500 mg/m2 over 10 minutes (days 1 and 15). Each cycle consists of 28 days, and can be repeated up to six times. Subsequently, bevacizumab will be administered every 2 weeks.	Drug: Paclitaxel, pemetrexed and bevacizumab and Toxicity symptoms will be collected using the STAR system During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m2 over 60 minutes on days 1 and 15, Pemetrexed 500mg/m2 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 19, 52. This treatment regimen will be given for a total of six cycles, or until documentation of disease progression, unacceptable toxicity or patient refusal. After the completion of six cycles, patients will continue on bevacizumab every 2 weeks until progression of disease, unacceptable toxicity or patient refusal to further participate. Other Names: Patients enrolled in this study will be evaluated clinically and with standard laboratory tests before and on days 1 and 15 of each 28-day cycle. Safety evaluations will consist of medical interviews, recording of adverse events, physical examinations, blood pressure, and laboratory measurements during each day of treatment. Patients will be evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study. To assess response, patients will have a CT scan of the chest, abdomen, pelvis and other clinical ly relevant sites after the first and second cycles, and every 2 cycles thereafter. During the maintenance phase, a CT scan of the chest, abdomen, pelvis and other clinically relevant sites after every 3 cycles.

Arms

Assigned Interventions

Experimental: Paclitaxel, Bevacizumab & Pemetrexed

Patients will be treated as follows: albumin-bound paclitaxel 125 mg/m2 over 120 minutes (days 1, 8, and 15), bevacizumab 10 mg/kg over 20 minutes (days 1 and 15), pemetrexed 500 mg/m2 over 10 minutes (days 1 and 15). Each cycle consists of 28 days, and can be repeated up to six times. Subsequently, bevacizumab will be administered every 2 weeks.

Drug: Paclitaxel, pemetrexed and bevacizumab and Toxicity symptoms will be collected using the STAR system

During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m2 over 60 minutes on days 1 and 15, Pemetrexed 500mg/m2 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 19, 52. This treatment regimen will be given for a total of six cycles, or until documentation of disease progression, unacceptable toxicity or patient refusal. After the completion of six cycles, patients will continue on bevacizumab every 2 weeks until progression of disease, unacceptable toxicity or patient refusal to further participate.

Other Names:

Patients enrolled in this study will be evaluated clinically and with
standard laboratory tests before and on days 1 and 15 of each 28-day cycle.
Safety evaluations will consist of medical interviews, recording of adverse
events, physical examinations, blood pressure, and laboratory measurements
during each day of treatment. Patients will be evaluated for adverse events
(all grades), serious adverse events, and adverse events requiring study drug
interruption or discontinuation at each study visit for the duration of their
participation in the study.
To assess response, patients will have a CT scan of the chest, abdomen, pelvis and other clinical
ly relevant sites after the first and second cycles, and every 2 cycles
thereafter. During the maintenance phase, a CT scan of the chest, abdomen, pelvis and other
clinically relevant sites after every 3 cycles.

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807573

Locations

United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
Sleepy Hollow, New York, United States

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Maria Pietanza, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00807573 History of Changes
Other Study ID Numbers:	08-109
Study First Received:	December 11, 2008
Last Updated:	January 31, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

BEVACIZUMAB (AVASTIN)
PEMETREXED (ALTIMA)
TAXOL (PACLITAXEL)
08-109

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Pemetrexed
Bevacizumab
Tubulin Modulators
Antimitotic Agents

Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013