A Phase II Study Of OSI-774 (NSC 718781) In Unresectable Or Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the stomach* or
gastroesophageal (GE) junction

- GE junction tumors include esophageal tumors arising 5 cm from the anatomic GE
junction or in the gastric cardia

- Locally advanced (i.e., unresectable) or metastatic disease NOTE: *Gastric
stratum temporarily closed to accrual as of 03/01/2003

- Unidimensionally measurable disease

- Target lesion must not be in previously irradiated field unless there is
documentation of clear progression

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver metastases present)

Renal:

- Creatinine no greater than 2 times ULN

Cardiovascular:

- No recent myocardial infarction

- No unstable angina

- No life-threatening arrhythmia

Gastrointestinal:

- No gastrointestinal tract disease resulting in an inability to take oral medication
or a requirement for IV alimentation

- No active peptic ulcer disease

- Must be able to swallow and/or receive enteral medications via gastrostomy feeding
tube

- No intractable nausea or vomiting

Ophthalmic:

- No history of corneal disease, including:

- Dry eye syndrome or Sjögren's syndrome

- Keratoconjunctivitis sicca

- Exposure keratopathy

- Fuch's dystrophy

- Other active disorders of the cornea

Other:

- HIV negative

- No active or uncontrolled infection

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission

- No severe psychiatric disorders

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior biologic therapy

- No concurrent anticancer immunotherapy

Chemotherapy:

- No prior chemotherapy for advanced or metastatic gastric cancer

- At least 8 weeks since prior adjuvant chemotherapy or chemotherapy given as a
radiosensitizer and recovered

- No concurrent anticancer chemotherapy

Endocrine therapy:

- No concurrent anticancer hormonal therapy

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy and recovered

- No concurrent anticancer radiotherapy

Surgery:

- At least 4 weeks since prior surgical procedure for stomach* or GE cancer and
recovered

- No prior surgical procedures that would affect absorption NOTE: *Gastric stratum
temporarily closed to accrual as of 03/01/2003

Other:

- No prior investigational drugs

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent anticancer therapy