Immunotoxin Therapy, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer
| Status: | Archived |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | January 2010 |
A Phase I Trial of SS1 ( dsFv) PE38 With Paclitaxel, Carboplatin, and Bevacizumab in Subjects With Unresectable Non-Small Cell Lung Adenocarcinoma
RATIONALE: Immunotoxins can find certain tumor cells and kill them without harming normal
cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
growth of tumor cells by blocking blood flow to the tumor. Giving immunotoxin therapy
together with paclitaxel, carboplatin, and bevacizumab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of immunotoxin when
given together with paclitaxel, carboplatin, and bevacizumab in treating patients with
advanced non-small cell lung cancer.
OBJECTIVES:
Primary
- To determine a safe and tolerable dose of SS1(dsFv)-PE38 immunotoxin in combination
with paclitaxel, carboplatin, and bevacizumab in patients with advanced
mesothelin-expressing non-small cell lung adenocarcinoma.
Secondary
- To assess the duration of response and progression-free survival of patients treated
with this regimen.
- To characterize the pharmacokinetics of this regimen in these patients.
- To monitor serum mesothelin levels before and during chemotherapy.
- To identify T-cell epitopes responsible for neutralizing SS1(dsFv)-PE38 immunotoxin
activity using mononuclear cells obtained by apheresis.
OUTLINE: This is a dose-escalation study of SS1(dsFv)-PE38 immunotoxin.
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab
IV over 30-90 minutes on day 1. Patients also receive SS1(dsFv)-PE38 immunotoxin IV over 30
minutes on days 2, 4, and 6 of courses 1 and 2. Treatment repeats every 21 days for 6
courses in the absence of disease progression or unacceptable toxicity. After 6 courses,
patients then receive bevacizumab alone every 21 days in the absence of disease progression
or unacceptable toxicity.
Patients undergo blood sample collection periodically for pharmacokinetic studies and
measurement of circulating serum mesothelin levels.
After completion of study treatment, patients are followed up every 2-3 months for up to 2
years.
We found this trial at
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National Cancer Institute (NCI) The National Cancer Institute (NCI) is part of the National Institutes...
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