Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer|
- To evaluate the response rate [ Time Frame: study completion ] [ Designated as safety issue: No ]
- To evaluate the duration of response [ Time Frame: study completion ] [ Designated as safety issue: No ]
- To evaluate the overall survival [ Time Frame: study completion ] [ Designated as safety issue: No ]
- To evaluate the quality of life [ Time Frame: study completion ] [ Designated as safety issue: No ]
- To describe the toxicity profile [ Time Frame: study completion ] [ Designated as safety issue: No ]
|Study Start Date:||March 2002|
|Study Completion Date:||January 2011|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Drug: Gemcitabine, Etoposide
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 combination.4.To describe the toxicity profile. 5.To collect clinical specimens from the defined study population for the evaluation of potential molecular correlates of diagnosis, disease progression, treatment outcomes, survival, and/or treatment-associated toxicity by proteomics and microarray technologies.
|United States, Michigan|
|Grand Rapids Clinical Oncology Program|
|Grand Rapids, Michigan, United States, 49503|
|Principal Investigator:||Marianne Lange, MD||Grand Rapids Clinical Oncology Program|