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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660699
• Other study ID #: 02-0580 / 201101866
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2008
• Last updated: May 7, 2015
• Start date: September 2002
• Est. completion date: September 2012

Study information

• Verified date: May 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2012
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Gemcitabine

• Docetaxel

Radiation:
• Radiation

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Severe Toxicities	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)	No
Secondary	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.	30 days after completion of treatment (treatment lasts approximately 19 weeks)	Yes
Secondary	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.	30 days after completion of treatment (treatment lasts approximately 19 weeks)	Yes
Secondary	Disease Free Survival (DFS) - Median	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)	No
Secondary	Overall Survival (OS) - Median	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)	No
Secondary	Overall Survival (OS)	OS was defined as the time from the initiation of treatment to death from any cause or last follow-up	1 year	No
Secondary	Overall Survival (OS)	OS was defined as the time from the initiation of treatment to death from any cause or last follow-up	2 years	No

External Links

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