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

September 12, 2005
June 3, 2013
March 2002
September 2007   (final data collection date for primary outcome measure)
To evaluate the response rate [ Time Frame: study completion ] [ Designated as safety issue: No ]
To evaluate the response rate
Complete list of historical versions of study NCT00202800 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To evaluate the duration of response
  • To evaluate the overall survival
  • To evaluate the quality of life
  • To describe the toxicity profile
Not Provided
Not Provided
 
Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Pancreatic Cancer
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2011
September 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00202800
VARI-002-1
Not Provided
Marianne Lange, MD, Spectrum Health
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
Principal Investigator: Marianne Lange, MD Grand Rapids Clinical Oncology Program
Spectrum Health Hospitals
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP