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

This study has been completed.
Sponsor:
Collaborators:
Van Andel Research Institute
Eli Lilly and Company
Battle Creek Health System
Hackley Hospital
Metropolitan Hospital, Michigan
Mecosta County General Hospital
Munson Medical Center
Saint Mary's Health Care
Information provided by:
Spectrum Health Hospitals
ClinicalTrials.gov Identifier:
NCT00202800
First received: September 12, 2005
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Gemcitabine, Etoposide
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Spectrum Health Hospitals:

Primary Outcome Measures:
  • To evaluate the response rate [ Time Frame: study completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: March 2002
Study Completion Date: January 2011
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gemcitabine, Etoposide
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202800

Locations
United States, Michigan
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Spectrum Health Hospitals
Van Andel Research Institute
Eli Lilly and Company
Battle Creek Health System
Hackley Hospital
Metropolitan Hospital, Michigan
Mecosta County General Hospital
Munson Medical Center
Saint Mary's Health Care
Investigators
Principal Investigator: Marianne Lange, MD Grand Rapids Clinical Oncology Program
  More Information

No publications provided

Responsible Party: Marianne Lange, MD, Spectrum Health
ClinicalTrials.gov Identifier: NCT00202800     History of Changes
Other Study ID Numbers: VARI-002-1
Study First Received: September 12, 2005
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Spectrum Health Hospitals:
Pancreatic Cancer
Gemcitabine/Etoposide
Ras-mutation

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Etoposide
Etoposide phosphate
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 30, 2014