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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Cholangiocarcinoma Cancer, Gallbladder Cancer, Pancreatic Cancer, Ampullary Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

throughout trial participation

Safety Issue:

No

Principal Investigator

Benjamin Tan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

02-0580 / 201101866

NCT ID:

NCT00660699

Start Date:

September 2002

Completion Date:

September 2012

Related Keywords:

  • Cholangiocarcinoma Cancer
  • Gallbladder Cancer
  • Pancreatic Cancer
  • Ampullary Cancer
  • Cholangiocarcinoma
  • Gallbladder
  • Pancreatic
  • Ampullary
  • Cancer
  • Pancreatic Neoplasms
  • Gallbladder Neoplasms
  • Cholangiocarcinoma

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110