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Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
This study has been completed.
Study NCT00009893   Information provided by National Cancer Institute (NCI)
First Received: February 2, 2001   Last Updated: October 16, 2009   History of Changes

February 2, 2001
October 16, 2009
May 2001
October 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00009893 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
Phase II Trial Of Gemcitabine, 5-Fluorouracil, And Leucovorin In Patients With Measurable Unresectable Or Metastatic Biliary Tract Carcinoma (Intrahepatic, Extrahepatic, Ampulla Of Vater) And Gallbladder Carcinoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have unresectable or metastatic biliary tract or gallbladder cancer.

OBJECTIVES: I. Determine the 6-month survival and overall survival of patients with unresectable or metastatic biliary tract carcinoma or gallbladder cancer treated with gemcitabine, fluorouracil, and leucovorin calcium. II. Determine the tumor response in these patients treated with this regimen. III. Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes followed by leucovorin calcium IV and fluorouracil IV over 5-10 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 22-45 patients will be accrued for this study within 1 to 2.5 years.

Phase II
Interventional
Treatment
  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • Drug: fluorouracil
  • Drug: gemcitabine hydrochloride
  • Drug: leucovorin calcium
 
Alberts SR, Al-Khatib H, Mahoney MR, Burgart L, Cera PJ, Flynn PJ, Finch TR, Levitt R, Windschitl HE, Knost JA, Tschetter LK. Gemcitabine, 5-fluorouracil, and leucovorin in advanced biliary tract and gallbladder carcinoma: a North Central Cancer Treatment Group phase II trial. Cancer. 2005 Jan 1;103(1):111-8.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
October 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically confirmed unresectable or metastatic biliary tract carcinoma (extrahepatic, intrahepatic, or ampulla of Vater) or gallbladder carcinoma Not amenable to combined chemotherapy and radiotherapy CNS metastases that are locally treatable (i.e., lesions treatable with surgery or radiotherapy) allowed if no evidence of progression for at least 4 weeks after completion of treatment

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 3.0 times upper limit of normal (ULN) AST no greater than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic or immunologic therapy No prior biologic or immunologic therapy for metastatic disease No concurrent immunotherapy No colony stimulating factors administered concurrently with first course of study therapy, or within 24 hours prior to subsequent courses Chemotherapy: See Disease Characteristics No prior gemcitabine No prior chemotherapy for metastatic disease At least 6 months since prior chemotherapy used as radiosensitization either in the adjuvant setting or for locally advanced disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Surgery: See Disease Characteristics

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00009893
 
CDR0000068421, NCCTG-N0042
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Steven R. Alberts, MD Mayo Clinic
National Cancer Institute (NCI)
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP