Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• 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 OR

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

• Measurable disease located outside prior radiotherapy port

• No carcinoid tumors or sarcomas

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

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

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

Hepatic:

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

• SGOT or SGPT no greater than 2.5 times ULN (5 times ULN if liver metastasis is present)

Renal:

• Creatinine clearance at least 30 mL/min

Cardiovascular:

• 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

Gastrointestinal:

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

• No intractable nausea or vomiting

• No malabsorption syndrome

Other:

• No severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil

• 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

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

• 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

Radiotherapy:

• 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

Surgery:

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

Other:

• No prior treatment for metastatic disease

• No other concurrent therapy for this cancer

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

Syma Iqbal

Study Chair

Heinz-Josef Lenz

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00033540
Information obtained from ClinicalTrials.gov on December 14, 2011

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