Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 5:21 PM
Study NCT ID:
NCT00126633
Status:
COMPLETED
Last Update Posted:
2012-09-17
First Post:
2005-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine, Cisplatin, and Bevacizumab in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
University of California, San Francisco
Organization:
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:
True
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?: