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A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma

Phase 2
18 Years
Not Enrolling
Extrahepatic Bile Duct Cancer, Gallbladder Cancer

Thank you

Trial Information

A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma


- 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

- 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

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.

Inclusion Criteria


- Histologically or cytologically confirmed gallbladder cancer or cholangiocarcinoma

- Locally advanced or metastatic disease that is unresectable

- Eligible subtypes:

- Adenocarcinoma, intestinal type

- Adenocarcinoma, not otherwise specified (NOS)

- Papillary carcinoma

- Clear cell adenocarcinoma

- Mucinous carcinoma

- Signet ring cell carcinoma

- Squamous cell carcinoma

- Adenosquamous carcinoma

- Small cell carcinoma

- Undifferentiated carcinoma

- Carcinoma, NOS


- Histologically confirmed adenocarcinoma of a metastatic site with clinical
documentation* of gallbladder or bile duct involvement and no evidence of another

NOTE: *If clinical documentation of gallbladder or bile duct involvement is not possible
due to removal of the organ, a clinically and/or radiographically consistent picture plus
pathologic findings from the metastatic site consistent with cholangiocarcinoma are

- Measurable disease located outside prior radiotherapy port

- No carcinoid tumors or sarcomas



- 18 and over

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified


- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 3 times upper limit of normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase
(SGPT) no greater than 2.5 times ULN (5 times ULN if liver metastasis is present)


- Creatinine clearance at least 30 mL/min


- No clinically significant cardiac disease that is not well controlled by medication

- No congestive heart failure

- No symptomatic coronary artery disease

- No cardiac arrhythmias

- No myocardial infarction within the past 12 months


- Able to swallow and/or receive medications via gastrostomy feeding tube

- No intractable nausea or vomiting

- No malabsorption syndrome


- No severe reaction to fluoropyrimidine therapy or known hypersensitivity to

- No other malignancy within the past 5 years except:

- Adequately treated basal cell or squamous cell skin cancer

- Carcinoma in situ of the cervix

- Adequately treated stage I or II cancer currently in complete remission

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- Prior neoadjuvant or adjuvant immunotherapy allowed provided therapy was completed at
least 1 year before documented recurrence or metastatic disease

- No concurrent immunotherapy


- Prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy allowed provided
therapy was completed at least 1 year before documented recurrence or metastatic

- No other concurrent chemotherapy

Endocrine therapy:

- Prior neoadjuvant or adjuvant hormonal therapy allowed provided therapy was completed
at least 1 year before documented recurrence or metastatic disease

- No concurrent hormonal therapy


- See Disease Characteristics

- See Chemotherapy

- Recovered from prior radiotherapy

- Prior neoadjuvant or adjuvant radiotherapy allowed provided therapy was completed at
least 1 year before documented recurrence or metastatic disease

- No prior radiotherapy to 25% or more of bone marrow

- No concurrent radiotherapy except for palliation of metastatic sites not considered
target lesions


- At least 2 weeks since prior surgery for this malignancy and recovered


- No prior treatment for metastatic disease

- No other concurrent therapy for this cancer

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

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.

Outcome Time Frame:

Patients assessed at least every six weeks while on protocol treatment

Safety Issue:


Principal Investigator

Syma Iqbal, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 2003

Completion Date:

July 2011

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • unresectable extrahepatic bile duct cancer
  • recurrent extrahepatic bile duct cancer
  • adenocarcinoma of the gallbladder
  • adenocarcinoma with squamous metaplasia of the gallbladder
  • squamous cell carcinoma of the gallbladder
  • adenocarcinoma of the extrahepatic bile duct
  • cholangiocarcinoma of the gallbladder
  • cholangiocarcinoma of the extrahepatic bile duct
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Cholangiocarcinoma



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