Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma
Condition: Gastric Cancer; Esophageal Neoplasms
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Intervention: irinotecan, docetaxel
Intervention description: docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.
Intervention MeSH terms: Docetaxel; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal cancer; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Summary:

      This study is for people with advanced gastric or gastroesophageal cancer. This study is
      being done to find out how long it takes tumors to grow after receiving treatment with the
      drugs irinotecan (also known as CPT-11) and docetaxel (also known as Taxotere). Irinotecan is
      a drug that has been approved by the Food and Drug Administration (FDA). Irinotecan has been
      approved for treatment of cancer of the colon and rectum. Docetaxel is another drug approved
      by the FDA. Docetaxel is approved for treatment of breast, prostate and lung cancer. However,
      the FDA has authorized the use of irinotecan and docetaxel in this study. This study will
      evaluate the effects of these drugs on participant's tumors. The side effects of the
      combination of irinotecan and docetaxel will also be evaluated. This study will also measure
      the levels of certain substances in participant's tumors. These substances, called genes
      (which are the cell's blueprint), affect how people's bodies react to the cancer drugs. Genes
      will also be measured in participant's blood. The researchers want to see if these substances
      can predict response to the study drugs.
    

Eligibility criteria:

        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.