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

Phase 2

Completed

Conditions: Gallbladder Cancer
Cholangiocarcinoma Cancer
Ampullary Cancer
Pancreatic Cancer

Interventions: Drug: Gemcitabine
Drug: Docetaxel
Radiation: Radiation

Registration Number: NCT00660699

Lead Sponsor: Washington University School of Medicine

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1 (gemcitabine, docetaxel, 5FU, radiation)	Radiation	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)
Arm 1 (gemcitabine, docetaxel, 5FU, radiation)	Gemcitabine	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)
Arm 1 (gemcitabine, docetaxel, 5FU, radiation)	Docetaxel	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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Toxicities Associated With Treatment (Grade 1-2)	30 days after completion of treatment (treatment lasts approximately 19 weeks)	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.
Disease Free Survival (DFS) - Median	Median follow-up was 24 months (range 3.2-97 months)	DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.
Overall Survival (OS) - Median	Median follow-up was 24 months (range 3.2-97 months)	OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.
Overall Survival (OS)	2 years	OS was defined as the time from the initiation of treatment to death from any cause or last follow-up
Toxicities Associated With Treatment (Grade 3-4)	30 days after completion of treatment (treatment lasts approximately 19 weeks)	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.