Ph I:Bevacizumab + Chemotherapy in Pts w/Malig Pleural Effusion Due to Adv NSCLC

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00250978
Phase
PHASE1
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • bevacizumab with chemotherapy, Pleur-XTM catheter placement — DRUG
    After Pleur-XTM catheter placement patients will receive bevacizumab 15mg/kg IV x 1 dose as a single agent.Three weeks later, chemotherapy will be initiated according to routine clinical practice along with continued use of bevacizumab.

Study Details

Your lung cancer has caused fluid to build up in the space around your lung. This fluid is called a malignant pleural effusion. This fluid takes up space in your chest, and prevents your lung from fully filling with air. As a result, you may be experiencing shortness of breath, cough, or chest discomfort. Your doctors have determined that you would feel better if a surgeon or pulmonary specialist removed this fluid immediately. Your doctors are offering to admit you to the hospital, and drain the fluid using a Pleur-XTM catheter. Once the Pleur-X catheter is in place, your doctors would like to start your chemotherapy. Your doctors have decided to treat you with chemotherapy. If the chemotherapy works to kill the cancer cells in your body, the cancer will make less fluid, and your doctors will be able to remove the Pleur-XTM catheter sooner. It is possible that adding a second drug to the chemotherapy, called bevacizumab may make he fluid dry up even faster. It is not known whether adding bevacizumab to chemotherapy for patients with a Pleur-XTM catheter in place is more helpful, or potentially more harmful, than using chemotherapy alone. For this reason, only patients enrolled in this research protocol can receive both chemotherapy and bevacizumab while they have a Pleur-XTM catheter in place. The purpose of this research study is to determine whether chemotherapy may be delivered safely with a Pleur-XTM catheter in place.

Key Dates

First listed
Nov 9, 2005
Start date
Nov 30, 2005
Status verified
Apr 2008
Primary completion
Apr 30, 2008
Completion
Apr 30, 2008

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

To assess the safety and feasibility of administering chemotherapy plus bevacizumab to patients with metastatic NSCLC and MPE following insertion of a Pleur-XTM catheter. [ Time Frame: end of study ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10021-

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By research site
Memorial Sloan-Kettering Cancer Center· New York, NY

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