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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00660699
Other study ID # 02-0580 / 201101866
Secondary ID
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


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
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