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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00660699
First received: April 11, 2008
Last updated: July 22, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • 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. [ Time Frame: 1 month after completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the toxicities associated with chemoradiation with sequential gemcitabine and docetaxel and 5FU in patients with pancreaticobiliary cancers. [ Time Frame: 30 days after completion of treatment ] [ Designated as safety issue: Yes ]
  • To describe the overall survival and disease-free survival in patients treated with adjuvant chemoradiation with sequential gemcitabine/docetaxel and 5FU. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00660699     History of Changes
Other Study ID Numbers: 02-0580 / 201101866
Study First Received: April 11, 2008
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Cholangiocarcinoma
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
Gemcitabine
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on October 16, 2014