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 Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Gemcitabine, Etoposide

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Grand Rapids Clinical Oncology Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the response rate	study completion

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the duration of response	study completion
To evaluate the overall survival	study completion
To evaluate the quality of life	study completion
To describe the toxicity profile	study completion

Collaborators and Investigators

• Sponsor: Spectrum Health Hospitals
• Collaborators: Eli Lilly and Company; Mercy Health System; Van Andel Research Institute; Munson Medical Center; Battle Creek Health System; Metropolitan Hospital, Michigan; Mecosta County General Hospital; Saint Mary's Health Network
• Investigators: Principal Investigator: Marianne Lange, MD, Grand Rapids Clinical Oncology Program

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimated): September 20, 2005

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Gemcitabine/Etoposide; Ras-mutation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide; Gemcitabine
• Other Study ID Numbers: VARI-002-1