A Phase II Study Of Intravenous Exatecan Mesylate (DX-891F) Administered Daily For Five Days Every Three Weeks To Patients With Previously Untreated Metastatic Gastric Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed gastric or gastroesophageal adenocarcinoma

- Lymph node involvement and/or distant metastasis

- No squamous cell carcinoma, small cell carcinoma, lymphoma, or leiomyosarcoma of the
stomach

- Measurable disease with indicator lesions outside the field of prior radiotherapy

- At least 20 mm by conventional scan OR

- At least 10 mm by spiral CT scan

- Nonmeasurable lesions include the following:

- Primary tumor

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonitis

- Cystic lesions

- Abdominal masses not confirmed and followed by imaging techniques

- No prior treatment for locally advanced or metastatic disease

- Prior adjuvant treatment allowed if disease recurrence noted at least 6 months
after completion of adjuvant treatment

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3

- Hemoglobin at least 9.0 g/dL

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if
liver metastases present)

- Albumin at least 2.8 g/dL

- PT or INR no greater than 1.5 times ULN (coumadin independent)

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No active congestive heart failure

- No uncontrolled angina

- No myocardial infarction within the past 6 months

Other:

- No concurrent serious infection

- No other malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No overt psychosis, mental disability, or incompetence that would preclude informed
consent

- No other life-threatening illness

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Biologic therapy:

- No concurrent anti-cancer biologic therapy

- No concurrent prophylactic colony stimulating factors during first course of therapy

Chemotherapy:

- Recovered from prior adjuvant chemotherapy

- No other concurrent anti-cancer chemotherapy

- No other concurrent anti-cancer cytotoxic therapy

Endocrine therapy:

- Concurrent megestrol for appetite stimulation allowed

Radiotherapy:

- At least 4 weeks since prior radiotherapy and recovered

- No prior wide-field radiotherapy to more than 25% of bone marrow

- No concurrent anti-cancer radiotherapy

Surgery:

- At least 4 weeks since prior major surgery and recovered

- No concurrent anti-cancer surgery

Other:

- No other investigational drugs (including analgesics or antiemetics) for at least 4
weeks prior to, during, and for 4 weeks after study