Clinical trial · Interventional
Efficacy Study of Gemcitabine, Paclitaxel, and Irradiation in the Treatment of Pancreatic Cancer
A Multicenter Phase II Trial of Weekly Gemcitabine, Paclitaxel, and Hyperfractionated External Irradiation (63.80 GY) for Locally Advanced Pancreatic Cancer
NCT00226746CI-TRIAL-00047233withdrawnPhase 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)
The purpose of this study is to find out what effects, good and bad, the chemotherapy drugs gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily radiation treatment on locally advanced 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 |
|---|---|---|---|
| Carcinoma, Pancreatic Ductal | Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel and gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel and Gemcitabine
- description
- Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions), Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36. Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36.
- interventionNames
- Drug: Paclitaxel and gemcitabine
Primary outcomes (1)
- measure
- One-year overall survival rate
- timeFrame
- Up to June 2010
- description
- Follow up for survival will be done to know this outcome
Secondary outcomes (2)
- measure
- Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically confirmed adenocarcinoma of the pancreas. 2. Patients must have locally advanced/unresectable disease based on institutional standardized criteria of unresectability. 3. Patients with residual disease after resection (R-1 or -2, micro and macroscopic residual) are eligible. 4. Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation. 5. All malignant disease must be encompassed within a single irradiation field (12 x 12 cm maximum). 6. All patients must have radiographically assessable disease. 7. Electrocardiogram (EKG), chest x-ray, abdominal computed tomography (CT)/magnetic resonance imaging (MRI) scan must be obtained within four weeks of study entry. 8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 9. Required entry laboratory parameters: granulocytes \>/= 1,800/µl, platelet count \>/= 100,000/µl, bilirubin \< 2.0 mg/dL, alanine aminotransferase (ALT) \< 3 x upper limit of normal, and creatinine \< 3.0 mg/dL. 10. Signed study-specific consent form prior to study entry. Exclusion Criteria: 1. Patients who have evidence of metastatic disease in the major viscera and/or peritoneal seeding or ascites. 2. Previous irradiation to the planned field; or previous chemotherapy for pancreatic cancer (Gemzar® or Taxol®). 3. Malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder. 4. Patients who have significant infection or other coexistent medical condition that would preclude protocol therapy.
References
Publications (1)
- BACKGROUNDAshamalla H, Zaki B, Mokhtar B, Colella F, Selim H, Krishnamurthy M, Ross P. Hyperfractionated radiotherapy and paclitaxel for locally advanced/unresectable pancreatic cancer. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):679-87. doi: 10.1016/s0360-3016(02)03791-4. PMID 12573755