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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Docetaxel; Gemcitabine

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