3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Biliary Duct or Gallbladder Cancer - Full Text View

Sponsors and Collaborators:	Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075504

Purpose

RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more cancer cells by making them more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with unresectable or metastatic bile duct or gallbladder cancer.

Condition	Intervention	Phase
Extrahepatic Bile Duct Cancer Gallbladder Cancer	Drug: gemcitabine hydrochloride Drug: triapine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study Of Triapine In Combination With Gemcitabine In Adenocarcinoma Of The Billiary Ducts And Gall Bladder

Resource links provided by NLM:

MedlinePlus related topics: Cancer Gallbladder Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride 3-Aminopyridine-2-carboxaldehyde thiosemicarbazone

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Objective response [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics [ Designated as safety issue: No ]
Progression-free and overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	78
Study Start Date:	January 2004
Estimated Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the objective response rate in patients with unresectable or metastatic biliary duct or gallbladder cancer treated with 3-AP (Triapine®) and gemcitabine.
Determine the toxic effects and recovery from toxic effects of this regimen in these patients.
Determine the survival and progression-free survival of patients treated with this regimen.

OUTLINE: This is a non-randomized, multicenter study. Patients are stratified according to bilirubin levels (normal vs abnormal).

Patients receive 3-AP (Triapine®) IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 1 additional course beyond CR.

Patients are followed every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 31-78 patients (10-29 with liver dysfunction and 21-49 without liver dysfunction) will be accrued for this study within 10-24.5 months.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed diagnosis of 1 of the following:
- Adenocarcinoma of the biliary duct
- Carcinoma of the ampulla of Vater
- Gallbladder cancer
Unresectable or metastatic disease
Measurable disease
- At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
No known brain metastases

PATIENT CHARACTERISTICS:

Age

18 to 90

Performance status

ECOG 0-2 OR
Karnofsky 60-100%

Life expectancy

More than 3 months

Hematopoietic

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
No glucose-6-phosphate dehydrogenase deficiency

Hepatic

Bilirubin no greater than 3 times upper limit of normal

Renal

Creatinine normal

Cardiovascular

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

Pulmonary

No uncontrolled pulmonary disease, including any of the following:
- Asthma
- Chronic bronchitis
- Chronic obstructive pulmonary disease
No requirement for chronic oxygen use

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
No ongoing or active infection
No other concurrent uncontrolled illness
No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy for the malignancy

Endocrine therapy

Not specified

Radiotherapy

At least 4 weeks since prior radiotherapy and recovered

Surgery

At least 4 weeks since prior definitive surgery and recovered
Recovered from prior surgical biopsy

Other

No other concurrent investigational agents
No other concurrent anticancer therapy
No concurrent combination antiretroviral therapy for HIV-positive patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075504

Locations

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Illinois
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615-7828
Simmons Cooper Cancer Institute
Springfield, Illinois, United States, 62794-9677
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46885-5099
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States, 49085
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, Missouri
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
CCOP - North Shore University Hospital
Manhassett, New York, United States, 11030
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
Mount Sinai Medical Center
New York, New York, United States, 10029
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Albert Einstein College of Medicine of Yeshiva University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Allyson J. Ocean, MD

Weill Medical College of Cornell University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000346767, AECM-0803945, NCI-6254
Study First Received:	January 9, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00075504 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

unresectable extrahepatic bile duct cancer
recurrent gallbladder cancer
unresectable gallbladder cancer
recurrent extrahepatic bile duct cancer
adenocarcinoma of the extrahepatic bile duct

Study placed in the following topic categories:

Antimetabolites
Gallbladder Diseases
Anti-Infective Agents
Biliary Tract Neoplasms
Digestive System Neoplasms
Immunologic Factors
Bile Duct Cancer, Extrahepatic
Immunosuppressive Agents
Antiviral Agents
Recurrence

Gall Bladder Cancer
Digestive System Diseases
Radiation-Sensitizing Agents
Bile Duct Diseases
Biliary Tract Diseases
Gastrointestinal Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Gemcitabine
Adenocarcinoma

Additional relevant MeSH terms:

Gallbladder Diseases
Antimetabolites
Anti-Infective Agents
Biliary Tract Neoplasms
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents

Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Bile Duct Diseases
Therapeutic Uses
Biliary Tract Diseases
Gallbladder Neoplasms
Bile Duct Neoplasms
Gemcitabine

ClinicalTrials.gov processed this record on September 04, 2009