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

The Washington University

Status and phase: Completed; Phase 2

Conditions: Gallbladder Cancer; Cholangiocarcinoma Cancer; Ampullary Cancer; Pancreatic Cancer

Treatments: Radiation: Radiation; Drug: Gemcitabine; Drug: Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00660699

02-0580 / 201101866

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Arm 1 (gemcitabine, docetaxel, 5FU, radiation)

Experimental group

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)

Treatment:

Drug: Docetaxel

Radiation: Radiation

Drug: Gemcitabine