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

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ClinicalTrials.gov Identifier: NCT00033540
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : August 28, 2012
Last Update Posted : September 12, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Description
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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.


Condition or disease Intervention/treatment Phase
Extrahepatic Bile Duct Cancer Gallbladder Cancer Drug: capecitabine Drug: gemcitabine hydrochloride Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2003
Actual Primary Completion Date : April 2008
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 Drug: capecitabine
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)


Outcome Measures
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Primary Outcome Measures :
  1. Response [ Time Frame: 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 :
  1. Overall Survival [ Time Frame: 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

  2. 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. ]
    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.

  3. Accrual of Patients With This Disease Site [ Time Frame: 1-20 months ]
    Only eligible patients who received treatment were evaluable for response and survival outcomes.

  4. 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. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • 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)

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033540


Locations
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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Syma Iqbal, MD University of Southern California
Study Chair: Heinz-Josef Lenz, MD University of Southern California
More Information
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Publications of Results:
Iqbal S, et al.: SWOG S0202: a phase II trial of gemcitabine and capecitabine in patients (pts) with unresectable or metastatic gallbladder cancer or cholangiocarcinoma. [Abstract] J Clin Oncol 24 (Suppl 18): A-4134, 2006.

Other Publications:

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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00033540    
Other Study ID Numbers: CDR0000069299
S0202 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: August 28, 2012
Last Update Posted: September 12, 2017
Last Verified: August 2017
Keywords provided by Southwest Oncology Group:
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
Additional relevant MeSH terms:
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Cholangiocarcinoma
Gallbladder Neoplasms
Bile Duct Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
 Bile Duct Diseases
Gemcitabine
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs