Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084604
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2004-06-10
Brief Title:
Irinotecan Cisplatin and Bevacizumab in Treating Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Open-Label Phase II Study of Irinotecan Cisplatin and Bevacizumab in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase II trial is studying how well giving irinotecan and cisplatin together with bevacizumab works in treating patients with unresectable or metastatic gastric stomach or gastroesophageal junction adenocarcinoma cancer Drugs used in chemotherapy such as irinotecan and cisplatin work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Giving chemotherapy together with a monoclonal antibody may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the efficacy of irinotecan cisplatin and bevacizumab in terms of time to progression in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
SECONDARY OBJECTIVES
I Determine other measures of efficacy including response rate and median and 1-year survival in patients treated with this regimen
II Determine the toxicity of this regimen in these patients III Correlate CT perfusion imaging results with the efficacy of this regimen in terms of time to progression objective response and survival in these patients
IV Determine the feasibility of serial serum proteomic assays in predicting response to therapy in terms of time to progression objective response and survival in patients treated with this regimen
V To bank paraffin stored tumor biopsy material for future planned immunohistochemistry studies to correlate with sensitivity to bevacizumab based combination chemotherapy
OUTLINE This is an open-label non-randomized multicenter study
Patients receive bevacizumab IV over 30-90 minutes on day 1 Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year
I Determine the efficacy of irinotecan cisplatin and bevacizumab in terms of time to progression in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
SECONDARY OBJECTIVES
I Determine other measures of efficacy including response rate and median and 1-year survival in patients treated with this regimen
II Determine the toxicity of this regimen in these patients III Correlate CT perfusion imaging results with the efficacy of this regimen in terms of time to progression objective response and survival in these patients
IV Determine the feasibility of serial serum proteomic assays in predicting response to therapy in terms of time to progression objective response and survival in patients treated with this regimen
V To bank paraffin stored tumor biopsy material for future planned immunohistochemistry studies to correlate with sensitivity to bevacizumab based combination chemotherapy
OUTLINE This is an open-label non-randomized multicenter study
Patients receive bevacizumab IV over 30-90 minutes on day 1 Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year
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 |
|---|---|---|---|
| U01CA099168 | NIH | None | httpsreporternihgovquickSearchU01CA099168 |
| 04-021 | None | None | None |
| NCI-6447 | None | None | None |
| MSKCC-04021 | None | None | None |
| CDR0000365463 | None | None | None |
| N01CM17105 | NIH | None | None |