Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202800
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2005-09-12
Brief Title:
Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
Spectrum Health Hospitals
Organization:
Spectrum Health Hospitals
Study Overview
Official Title:
Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2023-05
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:
Pancreatic cancer is a devastating disease Previous research shows a correlation between a specific oncogene change ras-mutation and enhanced sensitivity to two chemotherapy drugs combined gemcitabine and etoposide This Phase II trial will evaluate this drug combination for locally advanced and metastatic pancreatic cancer
Detailed Description:
This is a Phase II single-armed study evaluating potential benefits of the gemcitabine and etoposide combination in the treatment of patients with locally advanced or metastatic pancreatic cancer The study will involve approximately 30-40 adult patients with pancreatic cancer Response rate duration of response overall survival quality of life and toxicity associated with the combination therapy will be evaluated
Primary Objective To evaluate the response rate of patients with histologically or cytologically confirmed pancreatic cancer previously untreated with chemotherapy with the exception of 5FU given as part of an adjuvant regimen who receive the gemcitabine-etoposide combination therapy
Secondary Objectives 1 To evaluate the duration of response in the defined study population 2 To evaluate the overall survival 3 To evaluate the quality of life associated with this treatment combination4To describe the toxicity profile 5To collect clinical specimens from the defined study population for the evaluation of potential molecular correlates of diagnosis disease progression treatment outcomes survival andor treatment-associated toxicity by proteomics and microarray technologies
Primary Objective To evaluate the response rate of patients with histologically or cytologically confirmed pancreatic cancer previously untreated with chemotherapy with the exception of 5FU given as part of an adjuvant regimen who receive the gemcitabine-etoposide combination therapy
Secondary Objectives 1 To evaluate the duration of response in the defined study population 2 To evaluate the overall survival 3 To evaluate the quality of life associated with this treatment combination4To describe the toxicity profile 5To collect clinical specimens from the defined study population for the evaluation of potential molecular correlates of diagnosis disease progression treatment outcomes survival andor treatment-associated toxicity by proteomics and microarray technologies
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