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

Primary Purpose

Cholangiocarcinoma Cancer, Gallbladder Cancer, Pancreatic Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Gemcitabine

Docetaxel

Radiation

About this trial

This is an interventional treatment trial for Cholangiocarcinoma Cancer focused on measuring Cholangiocarcinoma, Gallbladder, Pancreatic, Ampullary, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1 (gemcitabine, docetaxel, 5FU, radiation)

Arm Description

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)

Outcomes

Primary Outcome Measures

Incidence of Severe Toxicities

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)

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)

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

DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.

Overall Survival (OS) - Median

OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.

Overall Survival (OS)

OS was defined as the time from the initiation of treatment to death from any cause or last follow-up

Overall Survival (OS)

OS was defined as the time from the initiation of treatment to death from any cause or last follow-up

Full Information

NCT ID

NCT00660699

First Posted

April 11, 2008

Last Updated

May 7, 2015

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00660699

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

September 2002 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiocarcinoma Cancer, Gallbladder Cancer, Pancreatic Cancer, Ampullary Cancer

Keywords

Cholangiocarcinoma, Gallbladder, Pancreatic, Ampullary, Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 (gemcitabine, docetaxel, 5FU, radiation)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Type

Radiation

Intervention Name(s)

Radiation

Primary Outcome Measure Information:

Title

Incidence of Severe Toxicities

Description

Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0

Time Frame

1 month after completion of treatment (treatment lasts approximately 19 weeks)

Secondary Outcome Measure Information:

Title

Toxicities Associated With Treatment (Grade 1-2)

Description

Time Frame

30 days after completion of treatment (treatment lasts approximately 19 weeks)

Title

Toxicities Associated With Treatment (Grade 3-4)

Description

Time Frame

30 days after completion of treatment (treatment lasts approximately 19 weeks)

Title

Disease Free Survival (DFS) - Median

Description

DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first.

Time Frame

Median follow-up was 24 months (range 3.2-97 months)

Title

Overall Survival (OS) - Median

Description

OS was defined as the time from the initiation of treatment to death from any cause or last follow-up.

Time Frame

Median follow-up was 24 months (range 3.2-97 months)

Title

Overall Survival (OS)

Description

OS was defined as the time from the initiation of treatment to death from any cause or last follow-up

Time Frame

1 year

Title

Overall Survival (OS)

Description

OS was defined as the time from the initiation of treatment to death from any cause or last follow-up

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Tan, M.D.

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

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