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Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II


OBJECTIVES:

- Determine the 6-month survival rate of patients with metastatic or recurrent carcinoma
of the esophagus or gastroesophageal junction treated with gemcitabine and irinotecan.

- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes
on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of
disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic or recurrent carcinoma of the esophagus or
gastroesophageal junction

- Squamous cell carcinoma OR

- Adenocarcinoma

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 to 100

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Not specified

Renal:

- Creatinine no greater than 1.5 times upper limit of normal

Cardiovascular:

- No uncontrolled hypertension

- No unstable angina

- No symptomatic congestive heart failure

- No myocardial infarction within the past 6 months

- No serious uncontrolled cardiac arrhythmia

Gastrointestinal:

- No active inflammatory bowel disease

- No significant bowel obstruction

- No chronic diarrhea

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No active infection requiring systemic therapy

- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately
treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 28 days since prior biologic therapy

- No prior biologic therapy for metastatic or recurrent disease

- No concurrent sargramostim (GM-CSF)

- No concurrent immunotherapy for tumor

Chemotherapy:

- At least 28 days since prior chemotherapy

- No prior chemotherapy for metastatic or recurrent disease

- No prior gemcitabine or irinotecan

- Prior adjuvant or neoadjuvant chemotherapy at time of initial diagnosis of localized
disease allowed

- No other concurrent chemotherapy for tumor

Endocrine therapy:

- See Disease Characteristics

- At least 28 days since prior endocrine therapy

- No prior endocrine therapy for metastatic or recurrent disease

- No concurrent hormonal therapy for tumor

Radiotherapy:

- At least 28 days since prior radiotherapy

- No prior radiotherapy for metastatic or recurrent disease

- Prior adjuvant or neoadjuvant radiotherapy at time of initial diagnosis of localized
disease allowed

- No concurrent radiotherapy for tumor

Surgery:

- Prior thoraco-abdominal surgery allowed

- At least 3 weeks since prior surgery and recovered

Other:

- No other concurrent anti-cancer therapy for tumor

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

6-month survival rate

Outcome Description:

To assess the six-month survival rate in patients with esophageal cancer treated with a gemcitabine-irinotecan combination chemotherapy regimen.

Outcome Time Frame:

6 months after registration

Safety Issue:

No

Principal Investigator

Stephen K. Williamson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Kansas

Authority:

United States: Federal Government

Study ID:

CDR0000068515

NCT ID:

NCT00012363

Start Date:

April 2001

Completion Date:

April 2006

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • stage IV esophageal cancer
  • recurrent esophageal cancer
  • adenocarcinoma of the stomach
  • squamous cell carcinoma of the esophagus
  • adenocarcinoma of the esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
University of California Davis Medical CenterSacramento, California  95817
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - DuluthDuluth, Minnesota  55805
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
University of Rochester Medical CenterRochester, New York  14642
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
OHSU Cancer InstitutePortland, Oregon  97239
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
City of Hope Comprehensive Cancer CenterDuarte, California  91010
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
MBCCOP-Howard University Cancer CenterWashington, District of Columbia  20060