Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126633
Status:
COMPLETED
Last Update Posted:
2012-09-17
First Post:
2005-08-02
Brief Title:
Gemcitabine Cisplatin and Bevacizumab in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Study of Fixed-Dose Rate Gemcitabine Cisplatin and Bevacizumab in Previously Untreated Patients With Metastatic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
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:
RATIONALE Drugs used in chemotherapy such as gemcitabine and cisplatin 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 gemcitabine and cisplatin together with bevacizumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving gemcitabine and cisplatin together with bevacizumab works in treating patients with metastatic pancreatic cancer
PURPOSE This phase II trial is studying how well giving gemcitabine and cisplatin together with bevacizumab works in treating patients with metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine time to disease progression in patients with previously untreated metastatic adenocarcinoma of the pancreas treated with gemcitabine cisplatin and bevacizumab
Determine the safety and toxicity of this regimen in these patients
Secondary
Determine the objective response rate in patients treated with this regimen
Determine the efficacy of this regimen in terms of the proportion of patients with a 50 decline in the CA19-9 biomarker in these patients
Determine the median survival of patients treated with this regimen
Correlate serum markers of angiogenesis and circulating tumor micrometastases with clinical outcome of patients treated with this regimen
OUTLINE This is an open-label non-randomized study
Patients receive gemcitabine IV over 100 minutes cisplatin IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients may receive additional study treatment at the discretion of the investigator
NOTE Patients may continue to receive other components of therapy if bevacizumab is discontinued due to toxicity
After completion of study treatment patients are followed at 28 days and then monthly thereafter
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 12-18 months
Primary
Determine time to disease progression in patients with previously untreated metastatic adenocarcinoma of the pancreas treated with gemcitabine cisplatin and bevacizumab
Determine the safety and toxicity of this regimen in these patients
Secondary
Determine the objective response rate in patients treated with this regimen
Determine the efficacy of this regimen in terms of the proportion of patients with a 50 decline in the CA19-9 biomarker in these patients
Determine the median survival of patients treated with this regimen
Correlate serum markers of angiogenesis and circulating tumor micrometastases with clinical outcome of patients treated with this regimen
OUTLINE This is an open-label non-randomized study
Patients receive gemcitabine IV over 100 minutes cisplatin IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients may receive additional study treatment at the discretion of the investigator
NOTE Patients may continue to receive other components of therapy if bevacizumab is discontinued due to toxicity
After completion of study treatment patients are followed at 28 days and then monthly thereafter
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 12-18 months
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 |
|---|---|---|---|
| GENENTECH-AVF2937s | None | None | None |
| UCSF-04451 | None | None | None |