Phase II Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma
- Patients must have clinically documented unresectable or metastatic gastric cancer or
gastroesophageal adenocarcinoma and histologic confirmation of the diagnosis with
- 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
- 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
- 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
- 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
- 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
- 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.