Study of Gemcitabine and Carboplatin in the Treatment of Metastatic or Recurrent Cholangiocarcinoma/Gallbladder Cancer - Full Text View

Sponsor:	Washington University School of Medicine
Information provided by (Responsible Party):	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00660140

Purpose

To determine the activity of gemcitabine combined with carboplatin in the treatment of patients with metastatic or recurrent cholangiocarcinoma or gallbladder cancer.

Condition	Intervention	Phase
Cholangiocarcinoma Gallbladder Cancer	Drug: Gemcitabine + Carboplatin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Gemcitabine and Carboplatin in the Treatment of Metastatic or Recurrent Cholangiocarcinoma/Gallbladder Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

To determine the activity of gemcitabine combined with carboplatin in the treatment of patients with metastatic or recurrent cholangiocarcinoma or gallbladder cancer. [ Time Frame: throughout trial participation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To describe the toxicities associated with gemcitabine and carboplatin in patients with cholangiocarcinoma or gallbladder cancer. [ Time Frame: throughout trial participation ] [ Designated as safety issue: Yes ]
To assess the clinical benefit, or lack thereof, of chemotherapy on patient's performance status and weight. [ Time Frame: throughout trial participation ] [ Designated as safety issue: No ]

Enrollment:	49
Study Start Date:	March 2002
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Gemcitabine at 1000 mg/m2 intravenously over 30 minutes on days 1 and 8 of a 21 day cycle

Followed by

Carboplatin at AUC of 5 intravenously over 60 minutes on day 1 of a 21 day cycle

Detailed Description:

To determine the activity of gemcitabine combined with carboplatin in the treatment of patients with metastatic or recurrent cholangiocarcinoma or gallbladder cancer.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have biopsy-proven locally-advanced, metastatic or recurrent adenocarcinoma of the biliary ducts or gallbladder.
Patients must have measurable disease.
Patients must be 18 years or older.
Patients must have a NCI CTC Performance Status of 0-2.
Patients must have a life expectancy of > 3 months.
Patients must not have any prior chemotherapy for metastatic disease. Prior adjuvant radiation therapy and chemotherapy with 5FU and/or gemcitabine is allowed.
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.
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:
- 1. Absolute neutrophil count > 1,500/mm3, platelet count > 100, 000/mm3, and hemoglobin > 9 g/dL.
- 2. Serum creatinine should be < 2 mg/dL.
- 3. Serum bilirubin should be < 3.0 mg/dL (biliary stents allowed).
- 4. 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660140

Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Benjamin Tan, M.D.

Washington University School of Medicine

More Information

Additional Information:

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Williams KJ, Picus J, Trinkhaus K, Fournier CC, Suresh R, James JS, Tan BR. Gemcitabine with carboplatin for advanced biliary tract cancers: a phase II single institution study. HPB (Oxford). 2010 Aug;12(6):418-26.

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00660140 History of Changes
Other Study ID Numbers:	01-0925
Study First Received:	April 11, 2008
Last Updated:	September 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

Cholangiocarcinoma
Gallbladder
Cancer

Additional relevant MeSH terms:

Gallbladder Neoplasms
Cholangiocarcinoma
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine

Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 09, 2012