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

May 7, 2015 updated by: Washington University School of Medicine

A Feasibility Phase II Study of Gemcitabine With Docetaxel With Concurrent 3-D Conformal Radiation Plus Continuous Infusion 5-Fluorouracil 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 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)
Drug: Gemcitabine
Other Names:
  • Gemzar
Drug: Docetaxel
Other Names:
  • Taxotere
Radiation: Radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Severe Toxicities
Time Frame: 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
1 month after completion of treatment (treatment lasts approximately 19 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Washington University School of Medicine

Publications and helpful links

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

Helpful Links

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 Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

April 11, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-0580 / 201101866

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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