Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021060
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2001-07-11
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:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase IIIII 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 IIIII 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 effusionIV 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 effusionIV 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 effusionIV 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 effusionIV 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 carboplatinTaxol - 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 effusionIV 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 effusionIV 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 effusionIV 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 effusionIV 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 carboplatinTaxol - 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068744 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA021115 |
| E4599 | None | None | None |
| U10CA021115 | NIH | None | None |