Clinical trial NCT00660699: A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholangiocarcinoma Cancer
Gallbladder Cancer
Pancreatic Cancer
Ampullary Cancer
Keywords: Cholangiocarcinoma
Gallbladder
Pancreatic
Ampullary
Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Severe Toxicities
timeFrame: 1 month after completion of treatment (treatment lasts approximately 19 weeks)
Secondary outcomes:
measure: Toxicities Associated With Treatment (Grade 1-2)
timeFrame: 30 days after completion of treatment (treatment lasts approximately 19 weeks)
measure: Toxicities Associated With Treatment (Grade 3-4)
timeFrame: 30 days after completion of treatment (treatment lasts approximately 19 weeks)
measure: Disease Free Survival (DFS) - Median
timeFrame: Median follow-up was 24 months (range 3.2-97 months)
measure: Overall Survival (OS) - Median
timeFrame: Median follow-up was 24 months (range 3.2-97 months)
measure: Overall Survival (OS)
timeFrame: 1 year
measure: Overall Survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Benjamin Tan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: