Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
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.
Inclusion Criteria:
- Patients with locally advanced or metastatic adenocarcinoma of the pancreas.
- Patients may have received prior immunotherapy, radiation therapy, or surgery, but
must be > 4 weeks out from therapy and have recovered fully from its effects.
- Patients must be 18 years of age or older.
- Patients must have unidimensional measurements obtainable using RECIST criteria (see
Protocol Attachment E).
- Karnofsky Performance Scale must be 50 or better (see Protocol Attachment A).
- Patient must have the following hematologic and chemical parameters:
- ANC > 1,000 cells/mm3
- Hemoglobin > 9 gm/dL
- Platelets > 100,000 cells/mm3
- SGOT/SGPT < 3 x normal, unless there is known liver involvement. Then they must
be < 5x normal.
- Bilirubin < 2.0 mg/dL
- Creatinine < 2.0 mg/dL
- Female within childbearing years must use an accepted contraceptive method.
- Patient must have a life expectancy of at least eight (8) weeks.
- A signed informed consent must be obtained prior to study entry.
Exclusion Criteria:
- Previous chemotherapy with the exception of 5FU given as part of an adjuvant regimen.
- Pregnant or nursing females.
- Concurrent radiation therapy.
- Patients with other active neoplasms are ineligible.
- Patients with serious active infections or other underlying medical conditions, which
would impair their ability to receive the treatment as prescribed.
Disease Diagnostic Criteria and Staging:
- Patients must have a histologic or cytologic diagnosis of locally advanced or
metastatic adenocarcinoma of the pancreas using standard pathologic criteria.
- Staging will be according to AJCC criteria.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
To evaluate the response rate
Outcome Time Frame:
study completion
Safety Issue:
No
Principal Investigator
Marianne Lange, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Grand Rapids Clinical Oncology Program
Authority:
United States: Food and Drug Administration
Study ID:
VARI-002-1
NCT ID:
NCT00202800
Start Date:
March 2002
Completion Date:
January 2011
Related Keywords:
- Pancreatic Cancer
- Pancreatic Cancer
- Gemcitabine/Etoposide
- Ras-mutation
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
