Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
NCT ID: NCT00202800
Last Updated: 2023-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2002-03-31
2011-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Van Andel Research Institute
OTHER
Eli Lilly and Company
INDUSTRY
Battle Creek Health System
OTHER
Mercy Health System
NETWORK
Metropolitan Hospital, Michigan
OTHER
Mecosta County General Hospital
UNKNOWN
Munson Medical Center
OTHER
Saint Mary's Health Network
OTHER
Spectrum Health Hospitals
OTHER
Responsible Party
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Spectrum Health
Principal Investigators
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Marianne Lange, MD
Role: PRINCIPAL_INVESTIGATOR
Grand Rapids Clinical Oncology Program
Locations
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Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Countries
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Other Identifiers
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VARI-002-1
Identifier Type: -
Identifier Source: org_study_id
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