Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00009893

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

101

Duration (Months)

2.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer	Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2001

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: gemcitabine + leucovorin + fluorouracil 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.	Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium

Arm

Intervention/Treatment

Experimental: gemcitabine + leucovorin + fluorouracil

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.

Drug: fluorouracil

Drug: gemcitabine hydrochloride

Drug: leucovorin calcium

Outcome Measures

Primary Outcome Measures

survival at 6 months [at 6 months]

Secondary Outcome Measures

overall survival [Up to 5 years]
tumor response rate [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	Mayo Clinic Jacksonville	Jacksonville	Florida	United States	32224
3	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
4	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
5	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
6	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
7	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
8	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
9	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
10	CCOP - Duluth	Duluth	Minnesota	United States	55805
11	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
12	CentraCare Clinic	Saint Cloud	Minnesota	United States	56303
13	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
14	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68131
15	Medcenter One Health System	Bismarck	North Dakota	United States	58501
16	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
17	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
18	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
19	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57104