A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cholangiocarcinoma Cancer, Gallbladder Cancer, Pancreatic Cancer, Ampullary Cancer

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Docetaxel
* Radiation: Radiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 (gemcitabine, docetaxel, 5FU, radiation)<br>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) | Drug: Gemcitabine<br> <br> * Other names: Gemzar;Drug: Docetaxel<br> <br> * Other names: Taxotere;Radiation: Radiation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Severe Toxicities | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0 | 1 month after completion of treatment (treatment lasts approximately 19 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities Associated With Treatment (Grade 1-2) | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome. | 30 days after completion of treatment (treatment lasts approximately 19 weeks) | 
| Toxicities Associated With Treatment (Grade 3-4) | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome. | 30 days after completion of treatment (treatment lasts approximately 19 weeks) | 
| Disease Free Survival (DFS) - Median | DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first. | Median follow-up was 24 months (range 3.2-97 months) | 
| Overall Survival (OS) - Median | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up. | Median follow-up was 24 months (range 3.2-97 months) | 
| Overall Survival (OS) | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up | 1 year | 
| Overall Survival (OS) | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangiocarcinoma, Gallbladder, Pancreatic, Ampullary, Cancer