Status:
COMPLETED
A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
Lead Sponsor:
Washington University School of Medicine
Conditions:
Cholangiocarcinoma Cancer
Gallbladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ch...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00660699
Start Date
September 1 2002
End Date
September 1 2012
Last Update
May 27 2015
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110