Clinical trial NCT00165464 (phase 2, status: completed)
Conditions: esophageal cancer, gastric cancer, ge junction cancer
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: taxotere, cisplatin, irinotecan
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H], [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=CC=CC=C4N=C13)C2=O
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, incurable esophageal or gastric carcinoma (carcinoma =
             adenocarcinoma or squamous cell carcinoma)

          -  Measurable disease > 1cm (longest diameter) by spiral CT scan or > 2cm by other
             radiographic technique.

          -  Lesions must be measurable in at least one dimension.

          -  Bone lesions, ascites and effusions are not measurable.

          -  Irradiated lesions are not measurable yet lesions arising in previously irradiated
             fields are measurable.

          -  Age 18+ years.

          -  ECOG performance status 0 or 1.

          -  Life expectancy greater than 12 weeks.

          -  Adequate bone marrow function.

          -  Adequate renal function: creatinine equal to or less than 1.5 mg/dl.

          -  SGOT less than 2.5 x institutional upper limit of normal if alkaline phosphatase is
             within institutional upper limit of normal.

          -  Alkaline phosphatase less than 4.0 x upper limit of normal if SGOT is within
             institutional upper limit of normal.

          -  For patients with both SGOT and alkaline phosphatase elevations, SGOT must be less
             than 1.5 x institutional upper limit of normal and alkaline phosphatase must be less
             2.5 x institutional upper limit of normal. For patients with liver metastases,
             however, SGOT may be < 3.0 x institutional upper limit of normal and alkaline
             phosphatase may be < 5.0 x institutional upper limit of normal as long as the total
             bilirubin is within the institutional upper limit of normal.

        Exclusion Criteria:

          -  No prior chemotherapy (except as part of pre- or post-operative therapy, completed > 1
             year prior to start date of this protocol).

          -  Patients who have received prior pelvic radiation therapy are ineligible. Other prior
             radiation therapy, however, is permitted, provided at least 4 weeks have elapsed since
             completion of this therapy and the initiation of this protocol.

          -  No myocardial infarction in the past six months.

          -  No major surgery in the past three weeks.

          -  No uncontrolled serious medical or psychiatric illness.

          -  No uncontrolled diarrhea.

          -  Patients with a peripheral neuropathy > grade 1 will be excluded.

          -  Women of childbearing potential must have a negative pregnancy test. Men and women of
             childbearing potential must use adequate contraception.

          -  No clinically apparent central nervous system metastases or carcinomatous meningitis.

          -  No other active malignancy other than non-melanoma skin cancer or in-situ cervical
             carcinoma. A resected cancer (other than in-situ carcinoma) must have demonstrated no
             evidence of recurrence for at least 3 years.

          -  Patients with history of severe hypersensitivity to irinotecan, cisplatin, taxotere or
             drugs formulated with polysorbate 80 must be excluded.