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


Phase 2
18 Years
N/A
Not Enrolling
Both
Extrahepatic Bile Duct Cancer, Gallbladder Cancer

Thank you

Trial Information

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


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.

Inclusion 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)

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response

Outcome Description:

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.

Outcome Time Frame:

Patients assessed at least every six weeks while on protocol treatment

Safety Issue:

No

Principal Investigator

Syma Iqbal, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069299

NCT ID:

NCT00033540

Start Date:

September 2003

Completion Date:

July 2011

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • 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

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
Providence Alaska Medical CenterAnchorage, Alaska  99508
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Great Falls ClinicGreat Falls, Montana  59405
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Spectrum Health Cancer Care - Butterworth CampusGrand Rapids, Michigan  49503-2560
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - KingmanKingman, Kansas  67068
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Pratt Cancer Center of KansasPratt, Kansas  67124
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Mecosta County General HospitalBig Rapids, Michigan  49307
Metropolitan HospitalGrand Rapids, Michigan  49506
Lacks Cancer Center at Saint Mary's Mercy Medical CenterGrand Rapids, Michigan  49503
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Northern Michigan HospitalPetoskey, Michigan  49770
Munson Medical CenterTraverse City, Michigan  49684
St. Francis Medical CenterCape Girardeau, Missouri  63701
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Sletten Regional Cancer InstituteGreat Falls, Montana  59405
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
St. Joseph Hospital Community Cancer CenterBellingham, Washington  98225
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Central Washington HospitalWenatchee, Washington  98801
Wenatchee Valley ClinicWenatchee, Washington  98801
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
North Bay Cancer CenterFairfield, California  94533
Marin Cancer Institute at Marin General HospitalGreenbrae, California  94904
Salina Regional Health CenterSalina, Kansas  67401
Louisiana State University Health Sciences Center - MonroeMonroe, Louisiana  71210
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
Good Samaritan HospitalDayton, Ohio  45406
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Community Oncology Group - IndependenceIndependence, Ohio  44131
South Central Kansas Regional Medical CenterArkansas City, Kansas  67005
Battle Creek Health SystemBattle Creek, Michigan  49017
Spectrum Health Hospital - Blodgett CampusGrand Rapids, Michigan  49506
Center for Cancer Care and ResearchSt. Louis, Missouri  63141
University Hospitals Ireland Cancer Center at Mercy Medical CenterCanton, Ohio  44708
Miami Valley HospitalDayton, Ohio  45409
Hematology Oncology Associates of Eastern IdahoIdaho Falls, Idaho  83404
West Florida Regional Medical CenterPensacola, Florida  32514-6088
Cancer Treatment Center at Christus Schumpert St. Mary PlaceShreveport, Louisiana  71101
Cancer Center at Iredell Memorial HospitalStatesville, North Carolina  28687-1828
McLeod Regional Medical CenterFlorence, South Carolina  29501
Orange Regional Medical Center - Horton CampusMiddletown, New York  10940-4199
Cancer Care Center at St. Francis HospitalIndianapolis, Indiana  46237
Cancer Center of Kansas - McPhersonMcPherson, Kansas  67460
Cancer Center at Thibodaux Regional Medical CenterThibodaux, Louisiana  70302-1118
Adirondack Cancer CareGlens Falls, New York  12801
Memorial Hospital of Martinsville and Henry CountyMartinsville, Virginia  24115-4788