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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00033540
Other study ID # CDR0000069299
Secondary ID S0202U10CA032102
Status Completed
Phase Phase 2
First received April 9, 2002
Last updated September 24, 2012
Start date September 2003
Est. completion date July 2011

Study information

Verified date September 2012
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date July 2011
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
capecitabine
650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days
gemcitabine hydrochloride
1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1,8, every 21 days

Locations

Country Name City State
United States Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico
United States Saint Anthony's Hospital at Saint Anthony's Health Center Alton Illinois
United States Veterans Affairs Medical Center - Amarillo Amarillo Texas
United States Providence Alaska Medical Center Anchorage Alaska
United States South Central Kansas Regional Medical Center Arkansas City Kansas
United States Mission Hospitals - Memorial Campus Asheville North Carolina
United States University of Colorado Cancer Center at University of Colorado Health Sciences Center Aurora Colorado
United States Battle Creek Health System Battle Creek Michigan
United States St. Joseph Hospital Community Cancer Center Bellingham Washington
United States Alta Bates Comprehensive Cancer Center Berkeley California
United States Mecosta County General Hospital Big Rapids Michigan
United States CCOP - Montana Cancer Consortium Billings Montana
United States University Hospitals Ireland Cancer Center at Mercy Medical Center Canton Ohio
United States Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Cape Girardeau Missouri
United States St. Francis Medical Center Cape Girardeau Missouri
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina
United States Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina
United States Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina
United States Adena Regional Medical Center Chillicothe Ohio
United States Charles M. Barrett Cancer Center at University Hospital Cincinnati Ohio
United States Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Memorial Hospital Cancer Center Colorado Springs Colorado
United States CCOP - Columbus Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States CCOP - Dayton Dayton Ohio
United States Good Samaritan Hospital Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Samaritan North Cancer Care Center Dayton Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Josephine Ford Cancer Center at Henry Ford Health System Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States North Bay Cancer Center Fairfield California
United States McLeod Regional Medical Center Florence South Carolina
United States Adirondack Cancer Care Glens Falls New York
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States CCOP - Grand Rapids Grand Rapids Michigan
United States Lacks Cancer Center at Saint Mary's Mercy Medical Center Grand Rapids Michigan
United States Metropolitan Hospital Grand Rapids Michigan
United States Spectrum Health Cancer Care - Butterworth Campus Grand Rapids Michigan
United States Spectrum Health Hospital - Blodgett Campus Grand Rapids Michigan
United States Great Falls Clinic Great Falls Montana
United States Sletten Regional Cancer Institute Great Falls Montana
United States Marin Cancer Institute at Marin General Hospital Greenbrae California
United States Sutter Health Western Division Cancer Research Group Greenbrae California
United States Bon Secours St. Francis Health System Greenville South Carolina
United States CCOP - Greenville Greenville South Carolina
United States Holland Community Hospital Holland Michigan
United States Hematology Oncology Associates of Eastern Idaho Idaho Falls Idaho
United States Community Oncology Group - Independence Independence Ohio
United States Cancer Care Center at St. Francis Hospital Indianapolis Indiana
United States CCOP - Kansas City Kansas City Missouri
United States Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City Kansas
United States Charles F. Kettering Memorial Hospital Kettering Ohio
United States Cancer Center of Kansas - Kingman Kingman Kansas
United States Fairfield Medical Center Lancaster Ohio
United States Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington Kentucky
United States Southwest Medical Center Liberal Kansas
United States Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas
United States USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California
United States Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio
United States Memorial Hospital of Martinsville and Henry County Martinsville Virginia
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States Middletown Regional Hospital Middletown Ohio
United States Orange Regional Medical Center - Horton Campus Middletown New York
United States Mobile Infirmary Medical Center Mobile Alabama
United States Louisiana State University Health Sciences Center - Monroe Monroe Louisiana
United States Hackley Hospital Muskegon Michigan
United States Tulane Cancer Center at Tulane University Hospital and Clinic New Orleans Louisiana
United States Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio
United States Cancer Center of Kansas - Newton Newton Kansas
United States Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange California
United States West Florida Regional Medical Center Pensacola Florida
United States Northern Michigan Hospital Petoskey Michigan
United States Cancer Institute at Oregon Health and Science University Portland Oregon
United States Pratt Cancer Center of Kansas Pratt Kansas
United States James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York
United States CCOP - St. Louis-Cape Girardeau Saint Louis Missouri
United States Center for Cancer Care and Research Saint Louis Missouri
United States David C. Pratt Cancer Center at St. John's Mercy Saint Louis Missouri
United States Cancer Center of Kansas - Salina Salina Kansas
United States Salina Regional Health Center Salina Kansas
United States Huntsman Cancer Institute at University of Utah Salt Lake City Utah
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Group Health Central Hospital Seattle Washington
United States Harborview Medical Center Seattle Washington
United States Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington
United States University Cancer Center at University of Washington Medical Center Seattle Washington
United States Veterans Affairs Medical Center - Seattle Seattle Washington
United States Cancer Treatment Center at Christus Schumpert St. Mary Place Shreveport Louisiana
United States Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana
United States Veterans Affairs Medical Center - Shreveport Shreveport Louisiana
United States Community Hospital of Springfield and Clark County Springfield Ohio
United States Hulston Cancer Center at Cox Medical Center South Springfield Missouri
United States St. John's Regional Health Center Springfield Missouri
United States Cancer Center at Iredell Memorial Hospital Statesville North Carolina
United States CCOP - Scott and White Hospital Temple Texas
United States Cancer Center at Thibodaux Regional Medical Center Thibodaux Louisiana
United States Munson Medical Center Traverse City Michigan
United States UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Central Washington Hospital Wenatchee Washington
United States Wenatchee Valley Clinic Wenatchee Washington
United States Associates in Womens Health Wichita Kansas
United States Cancer Center of Kansas, P.A. - Wichita Wichita Kansas
United States CCOP - Wichita Wichita Kansas
United States Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem North Carolina
United States Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio

Sponsors (2)

Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Overall Survival Measured from time of registration to death, or last contact date All patients will be followed until death or three years after registration, whichever is first. No
Secondary 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. 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. Yes
Secondary Accrual of Patients With This Disease Site Only eligible patients who received treatment were evaluable for response and survival outcomes. 1-20 months No
Secondary 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. All patients will be followed until death or three years after registration, whichever is first. No
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