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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 Foundation Cleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Washington University School of Medicine Saint Louis, Missouri  63110
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Swedish Cancer Institute Seattle, Washington  98104
Ochsner Clinic Foundation New Orleans, Louisiana  70121
UCSF Comprehensive Cancer Center San Francisco, California  94115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Tower Hematology Oncology Medical Group Los Angeles, California  90048
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Duke University Medical Center Durham, North Carolina  27710
University of Michigan Medical Center Ann Arbor, Michigan  48104-0914
Kansas City Oncology and Hematology Group Kansas City, Missouri  64111
Glendale Memorial Hospital Glendale, California  91204
Cancer Institute Medical Group Los Angeles, California  90025
University of Texas, MD Anderson Cancer Center Houston, Texas  77030
ACRC/Arizona Clinical Research Center Tucson, Arizona  85712
Comprehensive Cancer Center at DRMC Palm Springs, California  92262
Desert Regional Medical Center Palm Springs, California  92262
Sharp Clinical Oncology Research San Diego, California  92123
Denver VAMC Denver, Colorado  80220
Memorial Regional Comprehensive Cancer Center Weston, Florida  33326
The University of Chicago Chicago, Illinois  60637
Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology Chicago, Illinois  60611
LSU Health Sciences Center, Dept. of Medicine, Hematology/Oncology Shreveport, Louisiana  77130
Josephine Ford Cancer Center, Henry Ford Health System Detroit, Michigan  48202
The Sarah Cannon Cancer Center, Tennessee Oncology Nashville, Tennessee  37203