Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
Recruitment status was Active, not recruiting
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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 |
- To evaluate the response rate [ Time Frame: study completion ] [ Designated as safety issue: No ]
- 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 |
| Estimated Study Completion Date: | March 2009 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
-
Drug: Gemcitabine, Etoposide
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 |
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| United States, Michigan | |
| Grand Rapids Clinical Oncology Program | |
| Grand Rapids, Michigan, United States, 49503 | |
| 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: | December 29, 2009 |
| 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 Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Etoposide Etoposide phosphate Gemcitabine Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 16, 2013