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

NCT00033540 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000069299S0202U10CA032102
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 112

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.

Conditions

Extrahepatic Bile Duct Cancer; Gallbladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response

  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.

  Patients assessed at least every six weeks while on protocol treatment

Secondary Outcomes (4)

• Overall Survival

  All patients will be followed until death or three years after registration, whichever is first.

• Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

  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.

• Accrual of Patients With This Disease Site

  1-20 months

• Median Survival Time for Participants With Relevant Biologic Markers

  All patients will be followed until death or three years after registration, whichever is first.

Study Arms (1)

Capecitabine + Gemcitabine

EXPERIMENTAL

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; Drug: gemcitabine hydrochloride

Interventions

capecitabine DRUG

650 mg/m\^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days

Also known as: Xeloda (NSC-712807)

Capecitabine + Gemcitabine

gemcitabine hydrochloride DRUG

1000 mg/m\^2, intravenous (IV) over 100 minutes, Days 1,8, every 21 days

Also known as: Gemzar (NSC-613327)

Capecitabine + Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (112)

Mobile Infirmary Medical Center

Mobile, Alabama, 36652-2144, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99519-6604, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

North Bay Cancer Center

Fairfield, California, 94533, United States

Location

Marin Cancer Institute at Marin General Hospital

Greenbrae, California, 94904, United States

Location

Sutter Health Western Division Cancer Research Group

Greenbrae, California, 94904, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Memorial Hospital Cancer Center

Colorado Springs, Colorado, 80909, United States

Location

West Florida Regional Medical Center

Pensacola, Florida, 32514-6088, United States

Location

Hematology Oncology Associates of Eastern Idaho

Idaho Falls, Idaho, 83404, United States

Location

Saint Anthony's Hospital at Saint Anthony's Health Center

Alton, Illinois, 62002, United States

Location

Cancer Care Center at St. Francis Hospital

Indianapolis, Indiana, 46237, United States

Location

South Central Kansas Regional Medical Center

Arkansas City, Kansas, 67005, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7353, United States

Location

Cancer Center of Kansas - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas - McPherson

McPherson, Kansas, 67460, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Pratt Cancer Center of Kansas

Pratt, Kansas, 67124, United States

Location

Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67402, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, P.A. - Wichita

Wichita, Kansas, 67214-3728, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0084, United States

Location

Louisiana State University Health Sciences Center - Monroe

Monroe, Louisiana, 71210, United States

Location

Tulane Cancer Center at Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112, United States

Location

Cancer Treatment Center at Christus Schumpert St. Mary Place

Shreveport, Louisiana, 71101-0000, United States

Location

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, 71101-4295, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Cancer Center at Thibodaux Regional Medical Center

Thibodaux, Louisiana, 70302-1118, United States

Location

Battle Creek Health System

Battle Creek, Michigan, 49016, United States

Location

Mecosta County General Hospital

Big Rapids, Michigan, 49307, United States

Location

Josephine Ford Cancer Center at Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Mercy Medical Center

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Cancer Care - Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Metropolitan Hospital

Grand Rapids, Michigan, 49506, United States

Location

Spectrum Health Hospital - Blodgett Campus

Grand Rapids, Michigan, 49506, United States

Location

Holland Community Hospital

Holland, Michigan, 49423, United States

Location

Hackley Hospital

Muskegon, Michigan, 49443-3302, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

Cape Girardeau, Missouri, 63701, United States

Location

St. Francis Medical Center

Cape Girardeau, Missouri, 63701, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804-2263, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

Center for Cancer Care and Research

St Louis, Missouri, 63141, United States

Location

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Great Falls Clinic

Great Falls, Montana, 59403, United States

Location

Sletten Regional Cancer Institute

Great Falls, Montana, 59405, United States

Location

Veterans Affairs Medical Center - Albuquerque

Albuquerque, New Mexico, 87108-5138, United States

Location

Adirondack Cancer Care

Glens Falls, New York, 12801, United States

Location

Orange Regional Medical Center - Horton Campus

Middletown, New York, 10940-4199, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Mission Hospitals - Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27533, United States

Location

Cancer Center at Iredell Memorial Hospital

Statesville, North Carolina, 28687-1828, United States

Location

Forsyth Regional Cancer Center at Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

University Hospitals Ireland Cancer Center at Mercy Medical Center

Canton, Ohio, 44708, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Veterans Affairs Medical Center - Cincinnati

Cincinnati, Ohio, 45220-2288, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0501, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195-9001, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406-1891, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Community Oncology Group - Independence

Independence, Ohio, 44131, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750-1635, United States

Location

Middletown Regional Hospital

Middletown, Ohio, 45044-4898, United States

Location

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, 43055-2899, United States

Location

Community Hospital of Springfield and Clark County

Springfield, Ohio, 45505, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97201-3098, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

McLeod Regional Medical Center

Florence, South Carolina, 29501, United States

Location

Bon Secours St. Francis Health System

Greenville, South Carolina, 29601, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

Veterans Affairs Medical Center - Amarillo

Amarillo, Texas, 79106, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112-5550, United States

Location

Memorial Hospital of Martinsville and Henry County

Martinsville, Virginia, 24115-4788, United States

Location

St. Joseph Hospital Community Cancer Center

Bellingham, Washington, 98225, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98104, United States

Location

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98108, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Central Washington Hospital

Wenatchee, Washington, 98801, United States

Location

Wenatchee Valley Clinic

Wenatchee, Washington, 98801, United States

Location

Related Publications (2)

• Lurje G, Zhang W, Yang D, Groshen S, Hendifar AE, Husain H, Nagashima F, Chang HM, Fazzone W, Ladner RD, Pohl A, Ning Y, Iqbal S, El-Khoueiry A, Lenz HJ. Thymidylate synthase haplotype is associated with tumor recurrence in stage II and stage III colon cancer. Pharmacogenet Genomics. 2008 Feb;18(2):161-8. doi: 10.1097/FPC.0b013e3282f4aea6.

  PMID: 18192902 BACKGROUND

• Iqbal S, Rankin C, Lenz HJ, Gold PJ, Ahmad SA, El-Khoueiry AB, Messino MJ, Holcombe RF, Blanke CD. A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma: Southwest Oncology Group study S0202. Cancer Chemother Pharmacol. 2011 Dec;68(6):1595-602. doi: 10.1007/s00280-011-1657-1. Epub 2011 May 10.

  PMID: 21556747 RESULT

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms

Interventions

Capecitabine; Gemcitabine

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Study Statistician
• Organization: Southwest Oncology Group (SWOG) Statistical Center

206-667-4623

Study Officials

• Syma Iqbal, MD

  University of Southern California

  STUDY CHAIR

• Heinz-Josef Lenz, MD

  University of Southern California

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2003
• Primary Completion: April 1, 2008
• Study Completion: July 1, 2011
• Last Updated: September 12, 2017
• Results First Posted: August 28, 2012

Record last verified: 2017-08

Locations

US (112)