Tezacitabine With or Without 5-Fluorouracil (5-FU) for Advanced Esophageal Cancer or Gastric Cancer

Sponsor

Chiron Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00054873

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of tezacitabine when given alone or in combination with 5-fluorouracil (5-FU) to subjects who have advanced esophageal or gastric adenocarcinoma.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Neoplasms Stomach Neoplasms Adenocarcinoma	Drug: tezacitabine Drug: 5-fluorouracil	Phase 2

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2003

Study Completion Date :

Dec 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 disease.
Recovery from any serious (grade 3 or higher) toxic effects of prior radiation therapy.
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 100,000/mm3.
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 diarrhea.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	ACRC/Arizona Clinical Research Center	Tucson	Arizona	United States	85712
3	Glendale Memorial Hospital	Glendale	California	United States	91204
4	USC/Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
5	Tower Hematology Oncology Medical Group	Los Angeles	California	United States	90048
6	Comprehensive Cancer Center at DRMC	Palm Springs	California	United States	92262
7	Desert Regional Medical Center	Palm Springs	California	United States	92262
8	Sharp Clinical Oncology Research	San Diego	California	United States	92123
9	UCSF Comprehensive Cancer Center	San Francisco	California	United States	94115-1705
10	Cancer Institute Medical Group	Santa Monica	California	United States	90404
11	Denver VAMC	Denver	Colorado	United States	80220
12	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
13	Memorial Regional Comprehensive Cancer Center	Weston	Florida	United States	33326
14	Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology	Chicago	Illinois	United States	60611
15	The University of Chicago	Chicago	Illinois	United States	60637
16	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
17	LSU Health Sciences Center, Dept. of Medicine, Hematology/Oncology	Shreveport	Louisiana	United States	77130
18	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
19	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48109-0922
20	Josephine Ford Cancer Center, Henry Ford Health System	Detroit	Michigan	United States	48202
21	Kansas City Oncology and Hematology Group	Kansas City	Missouri	United States	64111
22	Washington University School of Medicine	St. Louis	Missouri	United States	63110
23	Duke University Medical Center	Durham	North Carolina	United States	27710
24	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
25	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
26	The Sarah Cannon Cancer Center, Tennessee Oncology	Nashville	Tennessee	United States	37203
27	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232
28	University of Texas, MD Anderson Cancer Center	Houston	Texas	United States	77030
29	Swedish Cancer Institute	Seattle	Washington	United States	98104