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Phase 2
18 Years
Not Enrolling
Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma

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Trial Information

Inclusion Criteria:

- Males and females greater than or equal to 18 years of age.

- Histologically confirmed recurrent (inoperable) or metastatic adenocarcinoma of the
esophagus, gastroesophageal junction, or stomach.

- At least one bidimensionally measurable lesion, not previously irradiated, with a
diameter that meets RECIST criteria, that can be serially measured. Intraluminal
tumors, evaluable only by endoscopy, are not acceptable as target lesions.

- Karnofsky Performance Score greater than or equal to 70%.

- Subjects must be in the second line therapy setting, thus they must have experienced
progression following treatment with one (and only one) prior chemotherapy regimen
used for the treatment of unresectable locally advanced, recurrent, or metastatic

- Recovery from any serious (grade 3 or higher) toxic effects of prior radiation

- Adequate hematologic profile: absolute neutrophil count greater than or equal to
1,500/mm3; hemoglobin greater than or equal to 9 g/dL; hematocrit greater than or
equal to 30% (transfusion allowed); and platelet count greater than or equal to

- Adequate hepatic function: bilirubin less than or equal to 1.5 mg/dL; AST and ALT
less that 2.5 X ULN (5 X ULN if liver involved with tumor); alkaline phosphatase less
than 5 X ULN

- Adequate renal function; serum creatinine less than or equal to 1.5 mg/dL or
calculated creatinine clearance greater than 50 mL/min.

- Both male and female subjects of childbearing potential must be using a contraceptive
method that is medically acceptable to the investigative center.

- Disease-free from a prior malignancy, other than non-melanoma skin cancer or
carcinoma in-situ of the cervix, for greater than 5 years.

Exclusion Criteria:

- Unstable angina or class III or IV New York Heart Association heart disease.

- CNS metastases.

- Pregnant or breast-feeding.

- Uncontrolled seizure disorder.

- Ongoing (grade 3 or higher) stomatitis, esophagopharyngitis, or uncontrolled

- Impaired nutritional status as evidenced by a serum albumin of 2.7 mg/dL or less.

- Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days
preceding the first study treatment. Concomitant anticancer therapy (chemotherapy,
immunotherapy, or radiation) or other investigational agents during study
participation or 28 days prior to study participation.

Type of Study:


Study Design:

Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

November 2003

Completion Date:

December 2004

Related Keywords:

  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Adenocarcinoma
  • Adenocarcinoma of the esophagus or stomach
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



Cleveland Clinic FoundationCleveland, Ohio  44195
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Washington University School of MedicineSaint Louis, Missouri  63110
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Swedish Cancer InstituteSeattle, Washington  98104
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Tower Hematology Oncology Medical GroupLos Angeles, California  90048
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Duke University Medical CenterDurham, North Carolina  27710
University of Michigan Medical CenterAnn Arbor, Michigan  48104-0914
Kansas City Oncology and Hematology GroupKansas City, Missouri  64111
Glendale Memorial HospitalGlendale, California  91204
Cancer Institute Medical GroupLos Angeles, California  90025
University of Texas, MD Anderson Cancer CenterHouston, Texas  77030
ACRC/Arizona Clinical Research CenterTucson, Arizona  85712
Comprehensive Cancer Center at DRMCPalm Springs, California  92262
Desert Regional Medical CenterPalm Springs, California  92262
Sharp Clinical Oncology ResearchSan Diego, California  92123
Denver VAMCDenver, Colorado  80220
Memorial Regional Comprehensive Cancer CenterWeston, Florida  33326
The University of ChicagoChicago, Illinois  60637
Northwestern University, Feinberg School of Medicine, Division of Hematology/OncologyChicago, Illinois  60611
LSU Health Sciences Center, Dept. of Medicine, Hematology/OncologyShreveport, Louisiana  77130
Josephine Ford Cancer Center, Henry Ford Health SystemDetroit, Michigan  48202
The Sarah Cannon Cancer Center, Tennessee OncologyNashville, Tennessee  37203