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S0202 Gemcit. and Capecit. for Pts w/Unresect Locally Adv Met Gallbladder Cancer or Cholangiocarcinoma
This study is ongoing, but not recruiting participants.

First Received on April 9, 2002.   Last Updated on July 13, 2011   History of Changes
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00033540
  Purpose

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 Intervention Phase
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Drug: capecitabine
Drug: gemcitabine hydrochloride
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Estimated Enrollment: 40
Study Start Date: September 2003
Arms Assigned Interventions
Experimental: Capecitabine + Gemcitabine
Capecitabine 650mg/m2 BID, PO at 12hr intervals, Days 1-14, q 21days; Gemcitabine 1000mg/m2, IV over 100 minutes, Days 1, 8, q 21days
Drug: capecitabine
650 mg/m2 BID, PO at 12 hour intervals, Days 1-14, q 21 days
Drug: gemcitabine hydrochloride
1000 mg/m2, IV over 100minutes, Days 1,8, q 21 days

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033540

  Show 112 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Syma Iqbal, MD USC/Norris Comprehensive Cancer Center
Study Chair: Heinz-Josef Lenz, MD USC/Norris Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
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.

Responsible Party: Laurence H. Baker, DO, Southwest Oncology Group - Group Chair's Office
ClinicalTrials.gov Identifier: NCT00033540     History of Changes
Other Study ID Numbers: CDR0000069299, SWOG-S0202
Study First Received: April 9, 2002
Last Updated: July 13, 2011
Health Authority: United States: Federal Government

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:
Gallbladder Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Bile Duct Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012