S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma

Phase 2

Completed

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, 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 combining gemcitabine with capecitabine in treating patients who have locally advanced or metastatic gallbladder cancer or cholangiocarcinoma.

Detailed Description: OBJECTIVES:

* Determine the response rates (confirmed complete and partial responses) in patients with unresectable, locally advanced or metastatic gallbladder cancer or cholangiocarcinoma treated with gemcitabine and capecitabine.

* Determine the overall survival of patients treated with this regimen.

* Determine the quantitative and qualitative toxic effects of this regimen in these patients.

* Determine the feasibility of accruing patients with these disease sites.

* Evaluate, preliminarily, relevant prognostic markers in these disease sites and the prognostic implications as predictors of survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 1-14 and gemcitabine IV over 100 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within approximately 10-20 months.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Capecitabine + Gemcitabine	gemcitabine hydrochloride	Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Capecitabine + Gemcitabine	capecitabine	Capecitabine 650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days

Primary Outcome Measures

Name	Time	Method
Response	Patients assessed at least every six weeks while on protocol treatment	Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	All patients will be followed until death or three years after registration, whichever is first.	Measured from time of registration to death, or last contact date
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug	Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment.	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. For each patient, worst grade of each event type is reported.
Accrual of Patients With This Disease Site	1-20 months	Only eligible patients who received treatment were evaluable for response and survival outcomes.
Median Survival Time for Participants With Relevant Biologic Markers	All patients will be followed until death or three years after registration, whichever is first.	To evaluate in a preliminary fashion relevant prognostic markers in gallbladder and cholangiocarcinoma which may have prognostic implications as predictors of survival. Overall survival measured from time of registration to death, or last contact date.

Locations (112): Mobile Infirmary Medical Center
🇺🇸
Mobile, Alabama, United States
Providence Alaska Medical Center
🇺🇸
Anchorage, Alaska, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
Alta Bates Comprehensive Cancer Center
🇺🇸
Berkeley, California, United States
North Bay Cancer Center
🇺🇸
Fairfield, California, United States
Marin Cancer Institute at Marin General Hospital
🇺🇸
Greenbrae, California, United States
Sutter Health Western Division Cancer Research Group
🇺🇸
Greenbrae, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸
Orange, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸
Aurora, Colorado, United States
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Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States