Phase II Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma

Inclusion Criteria:

- Patients must have clinically documented unresectable or metastatic gastric cancer or
gastroesophageal adenocarcinoma and histologic confirmation of the diagnosis with
tumor.

- Patients must have received one prior chemotherapeutic regimen for metastatic or
unresectable disease. Patients may not have received prior therapy with irinotecan
or a taxane.

- Tissue from tumor must be available. This may be paraffin embedded tissue from
previous biopsy/resection or if it is not available, a repeat biopsy must be
performed.

- Patients must agree to have a 20 cc blood sample drawn in addition to routine labs
with each cycle of chemotherapy.

- Patients must have measurable disease by clinical exam or radiologic studies, that is
at least one lesion measurable in at least one dimension, measuring 10 mm or more on
a spiral CT scan, or at least 20 mm by an exam or a non-spiral scan. If prior
radiation therapy was administered, measurable disease must be outside the radiation
field.

- Patients must have a Zubrod performance status of 0-2.

- Patients must have a predicted life expectancy of at least 12 weeks.

- Patients must have:

- a pre-treatment granulocyte count (i.e., segmented neutrophils + bands) of
>1,500/mm3,

- a hemoglobin level of greater than or equal to 9.0 gm/dl, and

- a platelet count of >100,000/mm3.

- Patients must have adequate renal function as documented by a calculated creatinine
clearance > 60.

- Patients must have adequate hepatic function as documented by a serum bilirubin less
than or equal to the institutional upper limit of normal, regardless of whether
patients have liver involvement secondary to tumor.

- No major surgery within 1 month of starting study drug.

- Women of childbearing potential must have a negative pregnancy test.

- Peripheral neuropathy: must be < grade 1

Exclusion Criteria:

- Patients may not have a history of an allergy to irinotecan.

- Patients with any active or uncontrolled infection, including known HIV infection.

- Patients with psychiatric disorders that would interfere with consent or follow-up.

- Patients with a history of myocardial infarction within the previous six months or
congestive heart failure requiring therapy.

- Pregnant or lactating women. Men and women of reproductive potential may not
participate unless they have agreed to use an effective contraceptive method while on
treatment and for at least 3 months thereafter.

- Presence of clinically apparent central nervous system metastases or carcinomatous
meningitis.

- Patients with a history of seizures are ineligible. Patients receiving phenytoin,
phenobarbital, or other anti-epileptic prophylaxis are ineligible.

- Patients with any other severe concurrent disease, which in the judgment of the
investigator would make the patient inappropriate for entry into this study.

- Patients with a history of severe hypersensitivity reaction to docetaxel or other
drugs formulated with polysorbate 80.