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A Phase II Trial of Paclitaxel, Pemetrexed, and Bevacizumab 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

[Protocol 08-109]

Full 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
Purpose :

The purpose of this study is to determine the percentage of patients with non-small cell lung cancer who experience shrinkage of their tumors following treatment with three anticancer drugs: paclitaxel, pemetrexed (Alimta®), and bevacizumab (Avastin®). Each of these medications has been approved by the FDA for patients who have not received any treatment for lung cancer. This study is evaluating the effects of all three drugs given at the same time.

Researchers also want to learn more about how to manage the side effects patients may experience during chemotherapy, such as nausea, pain, fatigue, diarrhea, constipation, or shortness of breath. These symptoms may be due to the cancer itself or to therapy. A special, secure Internet Web site 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 will help determine if STAR is a useful way to keep track of information about patients' symptoms and quality of life.

In addition, an automated technique of determining tumor size will be used with the routine CT scans that patients have as part of the study. This automated measurement method will allow doctors to know sooner whether the drug treatment is causing tumor shrinkage.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of stage IIIB or IV non-small cell lung cancer that has not yet been treated.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Maria Catherine Pietanza at 212-639-6373.

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