 |
|
A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Treatment | Active | 18 and over | 02-0580
NCT00660699 |
Trial Description
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. Further Study Information 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. 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:
Trial Contact Information
Trial Lead Organizations/Sponsors Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Benjamin Tan, M.D. | | Principal Investigator |
Trial Sites
|
|
|
|
| U.S.A. |
|
| Missouri |
|
| |
St. Louis |
|
| | | | | | | | | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
| | | Nicholas Fisher |
Ph: 314-454-5102 |
| |
Email:
nfisher@dom.wustl.edu |
|
See All Trial Sites
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00660699
Information obtained from ClinicalTrials.gov on May 13, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
Back to Top |
|
