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| ID | Type | Description | Link |
|---|---|---|---|
| UCCRC-12653A | |||
| NCI-2655 | |||
| OSU-0120 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy before surgery may may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is to see if bevacizumab, paclitaxel, and carboplatin given before surgery work in treating patients who have stage IB, stage II, or stage IIIA non-small cell lung cancer.
OBJECTIVES:
OUTLINE: Patients receive neoadjuvant bevacizumab IV over 60-90 minutes, paclitaxel IV over 3 hours, and carboplatin IV over 1 hour on day 1.
Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo surgical resection within 4-6 weeks after completion of chemotherapy.
Patients are followed within 3 months.
PROJECTED ACCRUAL: A total of 23-39 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Bevacizumab (15mg/kg, q3wk x 2), Paclitaxel (200 mg/m2, q3wk x 2), carboplatin (AUC of 6, q3wk x 2), followed by surgery 4 to 6 weeks after last dose of Bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological |
| ||
| carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (complete and partial responses by RECIST) | 4 years |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
No large central primary tumors in proximity to significant blood vessels
No bronchoscopically evident endobronchial tumors
At least 1 unidimensionally measurable lesion
No known brain metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Ann M. Mauer, MD | University of Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States | ||
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University |
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|
| paclitaxel | Drug |
|
| conventional surgery | Procedure |
|
| neoadjuvant therapy | Procedure |
|
| Columbus |
| Ohio |
| 43210 |
| United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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