Clinical trial · Interventional
Phase II Trial to Evaluate Gemcitabine and Etoposide for Locally Advanced or Metastatic Pancreatic Cancer
NCT00202800CI-TRIAL-00066868completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, Etoposide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the response rate
- timeFrame
- study completion
Secondary outcomes (4)
- measure
- To evaluate the duration of response
- timeFrame
- study completion
- measure
- To evaluate the overall survival
- timeFrame
- study completion
- measure
- To evaluate the quality of life
- timeFrame
- study completion
- measure
- To describe the toxicity profile
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.