A Phase II Study Of Intravenous T900607-Sodium In Subjects With Previously Treated Gastric Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed gastric or gastroesophageal junction
carcinoma (gastric carcinoma closed to accrual as of 02/04)

- Must have received 1 or 2 prior chemotherapy regimens for gastric carcinoma (gastric
carcinoma closed to accrual as of 02/04)

- Bidimensionally measurable disease

- At least 1 lesion that is at least 10 mm by CT scan

- No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3*

- Platelet count ≥ 100,000/mm^3*

- Hemoglobin ≥ 8.5 g/dL* NOTE: *Independent of growth factor or transfusion support

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 3 times ULN

- INR ≤ 1.5 (unless receiving anticoagulants)

- Albumin > 2.5 g/dL

Renal

- Creatinine ≤ 2 times ULN

Cardiovascular

- No New York Heart Association class III or IV heart disease

- LVEF ≥ 50%

- No acute anginal symptoms

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

- Able to comply with study procedures and follow-up

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No severe infection

- No other concurrent severe medical condition or comorbidity that would preclude study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 7 days since prior growth factors or blood transfusions

- No concurrent therapeutic biological response modifier therapy

- No concurrent immunotherapy

Chemotherapy

- See Disease Characteristics

- No other concurrent cytotoxic chemotherapy

Endocrine therapy

- No concurrent hormonal therapy

Radiotherapy

- No concurrent radiotherapy (including palliative radiotherapy)

Surgery

- More than 4 weeks since prior major surgery

Other

- More than 4 weeks since prior investigational agents

- No other concurrent investigational anticancer therapy