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Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine, Etoposide
Sponsored by
Spectrum Health Hospitals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Gemcitabine/Etoposide, Ras-mutation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Grand Rapids Clinical Oncology Program

Outcomes

Primary Outcome Measures

To evaluate the response rate

Secondary Outcome Measures

To evaluate the duration of response
To evaluate the overall survival
To evaluate the quality of life
To describe the toxicity profile

Full Information

First Posted
September 12, 2005
Last Updated
May 31, 2023
Sponsor
Spectrum Health Hospitals
Collaborators
Van Andel Research Institute, Eli Lilly and Company, Battle Creek Health System, Mercy Health System, Metropolitan Hospital, Michigan, Mecosta County General Hospital, Munson Medical Center, Saint Mary's Health Network
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1. Study Identification

Unique Protocol Identification Number
NCT00202800
Brief Title
Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
Official Title
Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Spectrum Health Hospitals
Collaborators
Van Andel Research Institute, Eli Lilly and Company, Battle Creek Health System, Mercy Health System, Metropolitan Hospital, Michigan, Mecosta County General Hospital, Munson Medical Center, Saint Mary's Health Network

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic Cancer, Gemcitabine/Etoposide, Ras-mutation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Etoposide
Intervention Description
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
Primary Outcome Measure Information:
Title
To evaluate the response rate
Time Frame
study completion
Secondary Outcome Measure Information:
Title
To evaluate the duration of response
Time Frame
study completion
Title
To evaluate the overall survival
Time Frame
study completion
Title
To evaluate the quality of life
Time Frame
study completion
Title
To describe the toxicity profile
Time Frame
study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Lange, MD
Organizational Affiliation
Grand Rapids Clinical Oncology Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grand Rapids Clinical Oncology Program
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer

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