Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT00021060
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2001-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Randomized Phase II/III Trial of Paclitaxel Plus Carboplatin With or Without Bevacizumab (NSC #704865) in Patients With Advanced Nonsquamous NSCLC
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. 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. Combining chemotherapy with a monoclonal antibody may kill more tumor cells. This randomized phase II/III trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have advanced, metastatic, or recurrent non-small cell lung cance
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess toxicity and survival in patients with advanced or metastatic (stage IIIB pleural effusion/IV), nonsquamous histology non-small cell lung cancer (NSCLC) treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase II) II. To assess response rates and time to progression in patients with advanced or metastatic (stage IIIB-pleural effusion/IV), nonsquamous histology NSCLC treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase II) III. To assess overall survival in patients with advanced or metastatic (stage IIIB-pleural effusion/IV), nonsquamous histology NSCLC treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase III) IV. To assess response rates, time to progression, and toxicity in patients with advanced or metastatic (stage IIIB-pleural effusion/IV), non-squamous histology NSCLC treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase III)
SECONDARY OBJECTIVES:
I. To determine if pre-treatment levels of plasma VEGF predict response to chemotherapy with carboplatin-Taxol with or without anti-VEGF monoclonal antibody (MAb).
II. To determine if pre-treatment plasma VEGF is of prognostic value in advanced NSCLC.
III. To determine whether elevated plasma levels of endothelial cell-specific proteins (VCAM, E-selectin), reflective of chemotherapy or anti-VEGF induced endothelial damage, are useful markers in assessing response to carboplatin/Taxol +/- anti-VEGF therapy.
IV. To determine whether pre- and post-treatment plasma levels of basic fibroblast growth factor (bFGF) is of prognostic value or predictive of response to therapy.
OUTLINE: This is a randomized study. Patients are stratified according to measurable disease (yes vs no), prior radiotherapy (yes vs no), weight loss (less than 5% vs 5% or more), and disease stage (IIIB vs IV vs recurrent). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1.
ARM II: Patients receive paclitaxel and carboplatin as in arm I followed by bevacizumab IV over 30-90 minutes on day 1.
Treatment in both arms repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of 6 courses, patients in arm II with stable or responding disease continue to receive bevacizumab only. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 842 patients will be accrued for this study.
I. To assess toxicity and survival in patients with advanced or metastatic (stage IIIB pleural effusion/IV), nonsquamous histology non-small cell lung cancer (NSCLC) treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase II) II. To assess response rates and time to progression in patients with advanced or metastatic (stage IIIB-pleural effusion/IV), nonsquamous histology NSCLC treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase II) III. To assess overall survival in patients with advanced or metastatic (stage IIIB-pleural effusion/IV), nonsquamous histology NSCLC treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase III) IV. To assess response rates, time to progression, and toxicity in patients with advanced or metastatic (stage IIIB-pleural effusion/IV), non-squamous histology NSCLC treated with carboplatin plus paclitaxel +/- bevacizumab. (Phase III)
SECONDARY OBJECTIVES:
I. To determine if pre-treatment levels of plasma VEGF predict response to chemotherapy with carboplatin-Taxol with or without anti-VEGF monoclonal antibody (MAb).
II. To determine if pre-treatment plasma VEGF is of prognostic value in advanced NSCLC.
III. To determine whether elevated plasma levels of endothelial cell-specific proteins (VCAM, E-selectin), reflective of chemotherapy or anti-VEGF induced endothelial damage, are useful markers in assessing response to carboplatin/Taxol +/- anti-VEGF therapy.
IV. To determine whether pre- and post-treatment plasma levels of basic fibroblast growth factor (bFGF) is of prognostic value or predictive of response to therapy.
OUTLINE: This is a randomized study. Patients are stratified according to measurable disease (yes vs no), prior radiotherapy (yes vs no), weight loss (less than 5% vs 5% or more), and disease stage (IIIB vs IV vs recurrent). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1.
ARM II: Patients receive paclitaxel and carboplatin as in arm I followed by bevacizumab IV over 30-90 minutes on day 1.
Treatment in both arms repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of 6 courses, patients in arm II with stable or responding disease continue to receive bevacizumab only. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 842 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| E4599 | None | None | View | |
| U10CA021115 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000068744 | REGISTRY | PDQ (Physician Data Query) | View |