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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00660699
First Posted: April 17, 2008
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
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.

Condition Intervention Phase
Cholangiocarcinoma Cancer Gallbladder Cancer Pancreatic Cancer Ampullary Cancer Drug: Gemcitabine Drug: Docetaxel Radiation: Radiation Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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


Enrollment: 50
Study Start Date: September 2002
Study Completion Date: September 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Gemzar
Drug: Docetaxel
Other Name: Taxotere
Radiation: Radiation

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660699


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Benjamin Tan, M.D. Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00660699     History of Changes
Other Study ID Numbers: 02-0580 / 201101866
First Submitted: April 11, 2008
First Posted: April 17, 2008
Results First Submitted: March 30, 2015
Results First Posted: May 27, 2015
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Washington University School of Medicine:
Cholangiocarcinoma
Gallbladder
Pancreatic
Ampullary
Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Cholangiocarcinoma
Gallbladder Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Gemcitabine
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators