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| 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 |
| 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
|
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed gallbladder cancer or cholangiocarcinoma
Eligible subtypes:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
Other:
No other malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 112 Study Locations| Study Chair: | Syma Iqbal, MD | USC/Norris Comprehensive Cancer Center |
| Study Chair: | Heinz-Josef Lenz, MD | USC/Norris Comprehensive Cancer Center |
More Information
| 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 |
|
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 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 |