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Extrahepatic Bile Duct CancerPhase 2NCT00033540

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

A Phase 2 study testing capecitabine and gemcitabine hydrochloride in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by SWOG Cancer Research Network at 112 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
capecitabine and gemcitabine hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
112 sitesUnited States
Study dates
Sep 2003to Jul 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

112 sites in 1 country.

112 sites in 1 country

United States112 sites

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108-5138

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

    Alton, Illinois, 62002

  • Veterans Affairs Medical Center - Amarillo

    Amarillo, Texas, 79106

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99519-6604

  • South Central Kansas Regional Medical Center

    Arkansas City, Kansas, 67005

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

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

    Aurora, Colorado, 80010

  • Battle Creek Health System

    Battle Creek, Michigan, 49016

  • St. Joseph Hospital Community Cancer Center

    Bellingham, Washington, 98225

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • Mecosta County General Hospital

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • University Hospitals Ireland Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • St. Francis Medical Center

    Cape Girardeau, Missouri, 63701

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267-0501

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195-9001

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406-1891

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Josephine Ford Cancer Center at Henry Ford Health System

    Detroit, Michigan, 48202

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • North Bay Cancer Center

    Fairfield, California, 94533

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Adirondack Cancer Care

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27533

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Mercy Medical Center

    Grand Rapids, Michigan, 49503

  • Spectrum Health Cancer Care - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Metropolitan Hospital

    Grand Rapids, Michigan, 49506

  • Spectrum Health Hospital - Blodgett Campus

    Grand Rapids, Michigan, 49506

  • Great Falls Clinic

    Great Falls, Montana, 59403

  • Sletten Regional Cancer Institute

    Great Falls, Montana, 59405

  • Marin Cancer Institute at Marin General Hospital

    Greenbrae, California, 94904

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Hematology Oncology Associates of Eastern Idaho

    Idaho Falls, Idaho, 83404

  • Community Oncology Group - Independence

    Independence, Ohio, 44131

  • Cancer Care Center at St. Francis Hospital

    Indianapolis, Indiana, 46237

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

    Kansas City, Kansas, 66160-7353

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Cancer Center of Kansas - Kingman

    Kingman, Kansas, 67068

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0084

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750-1635

  • Memorial Hospital of Martinsville and Henry County

    Martinsville, Virginia, 24115-4788

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • Orange Regional Medical Center - Horton Campus

    Middletown, New York, 10940-4199

  • Middletown Regional Hospital

    Middletown, Ohio, 45044-4898

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Louisiana State University Health Sciences Center - Monroe

    Monroe, Louisiana, 71210

  • Hackley Hospital

    Muskegon, Michigan, 49443-3302

  • Tulane Cancer Center at Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055-2899

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

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

    Orange, California, 92868

  • West Florida Regional Medical Center

    Pensacola, Florida, 32514-6088

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97201-3098

  • Pratt Cancer Center of Kansas

    Pratt, Kansas, 67124

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

    Rochester, New York, 14642

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67402

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112-5550

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98104

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • Cancer Treatment Center at Christus Schumpert St. Mary Place

    Shreveport, Louisiana, 71101-0000

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71101-4295

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana, 71130-3932

  • St. John's Regional Health Center

    Springfield, Missouri, 65804-2263

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • Center for Cancer Care and Research

    St Louis, Missouri, 63141

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

    St Louis, Missouri, 63141

  • Cancer Center at Iredell Memorial Hospital

    Statesville, North Carolina, 28687-1828

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Cancer Center at Thibodaux Regional Medical Center

    Thibodaux, Louisiana, 70302-1118

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Central Washington Hospital

    Wenatchee, Washington, 98801

  • Wenatchee Valley Clinic

    Wenatchee, Washington, 98801

  • Associates in Womens Health

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, P.A. - Wichita

    Wichita, Kansas, 67214-3728

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Forsyth Regional Cancer Center at Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: A Phase II Trial of Gemcitabine (NSC-613327) and Capecitabine (NSC-712807) in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma

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.

Read the 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.

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
Medical subject headings
Bile Duct Neoplasms, Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • capecitabineDrug

    Also called Xeloda (NSC-712807)

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

  • gemcitabine hydrochlorideDrug

    Also called Gemzar (NSC-613327)

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

Study groups in NCT00033540
Study groupRoleWhat they receive
Capecitabine + GemcitabineExperimentalCapecitabine 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
Receives: Drug: capecitabine; Drug: gemcitabine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Patients assessed at least every six weeks while on protocol treatment

Secondary outcomes (4)

  1. Overall Survival

    Measured from time of registration to death, or last contact date

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

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

    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.

    Measured: 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.

  3. Accrual of Patients With This Disease Site

    Only eligible patients who received treatment were evaluable for response and survival outcomes.

    Measured: 1-20 months

  4. Median Survival Time for Participants With Relevant Biologic Markers

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 2003
  3. Primary completionApr 2008
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00033540
Sponsor's protocol ID
CDR0000069299
Other IDs
S0202, U10CA032102
Status last verified
Aug 2017
First submitted
9 Apr 2002
Last updated
12 Sep 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18192902

  • 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.

    PubMed 21556747

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine and gemcitabine hydrochloride in people with Extrahepatic Bile Duct Cancer and Gallbladder Cancer, run by SWOG Cancer Research Network at 112 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response (time frame: Patients assessed at least every six weeks while on protocol treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00033540, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.

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