S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma
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.
Extrahepatic Bile Duct Cancer
Drug: gemcitabine hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma|
- Response [ Time Frame: Patients assessed at least every six weeks while on protocol treatment ] [ Designated as safety issue: No ]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.
- Overall Survival [ Time Frame: All patients will be followed until death or three years after registration, whichever is first. ] [ Designated as safety issue: No ]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 [ Time Frame: 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. ] [ Designated as safety issue: Yes ]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 [ Time Frame: 1-20 months ] [ Designated as safety issue: No ]Only eligible patients who received treatment were evaluable for response and survival outcomes.
- Median Survival Time for Participants With Relevant Biologic Markers [ Time Frame: All patients will be followed until death or three years after registration, whichever is first. ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2003|
|Study Completion Date:||July 2011|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Experimental: Capecitabine + Gemcitabine
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
650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days
Other Name: Xeloda (NSC-712807)Drug: gemcitabine hydrochloride
1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1,8, every 21 days
Other Name: Gemzar (NSC-613327)
- 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.
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|Study Chair:||Syma Iqbal, MD||University of Southern California|
|Study Chair:||Heinz-Josef Lenz, MD||University of Southern California|