A Feasibility Phase II Study In The Treatment Of Resected Cholangiocarcinoma, Gallbladder, Pancreatic And Ampullary Cancers

Study Overview

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

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.

N/A

Cholangiocarcinoma Cancer
Gallbladder Cancer
Pancreatic Cancer
Ampullary Cancer

DRUG: Gemcitabine
DRUG: Docetaxel
RADIATION: Radiation

02-0580 / 201101866

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-04-11	Results First Submitted 2015-03-30	Last Update Submitted that met QC Criteria 2015-05-07
First Submitted that Met QC Criteria 2008-04-16	Results First Submitted that Met QC Criteria 2015-05-07	Last Update Posted (ESTIMATED) 2015-05-27
First Posted (ESTIMATED) 2008-04-17	Results First Posted 2015-05-27	Last Verified 2015-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm 1 (gemcitabine, docetaxel, 5FU, 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 c	DRUG: Gemcitabine DRUG: Docetaxel RADIATION: Radiation

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm 1 (gemcitabine, docetaxel, 5FU, 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 c

DRUG: Gemcitabine

DRUG: Docetaxel

RADIATION: Radiation

Primary Outcome Measures	Measure Description	Time Frame
Incidence of Severe Toxicities	Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0	1 month after completion of treatment (treatment lasts approximately 19 weeks)

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

None

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Benjamin Tan, M.D., Washington University School of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record