Clinical trial · Interventional
A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
A Feasibility Phase II Study of Gemcitabine With Docetaxel With Concurrent 3-D Conformal Radiation Plus Continuous Infusion 5-Fluorouracil in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
NCT00660699CI-TRIAL-00018037completedPhase 2Results postedClinicalTrials.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)
To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampullary Cancer | Ampulla of Vater Carcinoma | ALIAS | 0.90 |
| Cholangiocarcinoma Cancer | — | UNRESOLVED | — |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1 (gemcitabine, docetaxel, 5FU, radiation)
- description
- Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
- interventionNames
- Drug: Gemcitabine
- Drug: Docetaxel
- Radiation: Radiation
Primary outcomes (1)
- measure
- Incidence of Severe Toxicities
- timeFrame
- 1 month after completion of treatment (treatment lasts approximately 19 weeks)
- description
- Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma. * Patients must be 18 years or older. * Patients must have a NCI CTC Performance Status of 0-2. * Patients must not have any prior chemotherapy or radiation therapy for this current malignancy. * At least 3 weeks should have elapsed since any surgery requiring general anesthesia. * Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ, unless in remission for \>5years * Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy. * Initial Required Laboratory Values: * Absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥ 9 g/dL. * Serum creatinine should be ≤ 2 mg/dL. * Serum bilirubin should be ≤ 3.0 mg/dL (biliary stents allowed). * Serum transaminases should be ≤ 5-fold the institutional upper limits. * Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection. * Patients must be able to sign an informed consent. Exclusion Criteria: * None
References
Publications (0)
Data not yet available
No reference posted for this study.