Docetaxel, Oxaliplatin, and Fluorouracil in Treating Patients With Metastatic or Unresectable Stomach Cancer, Gastroesophageal Junction Cancer, or Other Solid Tumor

The MTD will be determined using a 3+3 dose escalating design. There will be 5 dose cohorts: Cohort 1a 25mg/m2 Cohort 2a 30mg/m2 Cohort 3a 40 mg/m2 Cohort 4a 50 mg/m2 Cohort 5a 60 mg/m2 3 patients will be enrolled at dose of 25mg/m2 docetaxel. If no dose limiting toxicities (DLTs) are seen then dose will be escalated to next cohort and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, experience a DLT then MTD will be determined to be at this dose level. If 2 or more DLTs are seen in first 3 patients at that dose, then MTD will be one dose lower to the level where the DLTs were experienced. Dose of docetaxel will be escalated by use of cohorts until the MTD for phase II is determined. DLTs were defined using the National Cancer Institute Common Toxicity Criteria Version 3.0

Time frame: After completion of 1 cycle of therapy (1 cycle = 14 days)

Population: Dose of docetaxel was escalated up through 5 cohorts.

Overall Response Rate (ORR) is defined as Complete Response (CR) plus Partial Response (PR) and will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan. Complete Response (CR) - Disappearance of all target lesions. Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease, neither sufficient shrinkage to qualify for Partial disease nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD while on study. Progressive Disease - \<=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Time frame: After 4 cycles of therapy (1 cycle = 14 days)

Population: One patient that was registered to phase II did not get treated on study and was therefore not evaluable. Two patients did not reach first response at 4 cycles and therefore were not evaluable.

Dose limiting toxicities (DLT) will be graded according to National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0) except for neurosensory. The occurrence of any of the following during the 1st cycle, seen in more than one patient, will constitute a DLT. Grade 3 non-hematologic toxicity(except alopecia) Grade 4 thrombocytopenia, not recovered to platelet count of \>75,000/ul by day 15. Grade 4 neutropenia, not recovered to count of \>1,500/ul by day 15. Grade 4 neutropenia with fever or infection. Grade 2 neurologic-sensory toxicity not recovered to grade 1 or better by day 15

Time frame: After 1 cycle of therapy (1 cycle = 14 days)

Population: 15 patients enrolled in 5 dose escalating cohorts were monitored for DLTs in the phase I part of the study.

Time frame: Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle

Population: Data not collected.

Time frame: Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle

Population: Data not collected.

Time frame: Blood sample cycle 1 day 1 and toxicity on day 1 of each cycle

Population: Data not collected.

Toxicity data will be collected on day 1 of every 14 day cycle during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events (AE) version 3.0 (CTCAE v3.0). For patients that experience multiple grades of the same AE that is determined to be at least possibly related to at least one study drug, only highest grade will be collected. In general AEs will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

Time frame: Day 1 of each cycle of therapy with 1 cycle =14 days until disease progression for up to a maximum of 34 cycles and 30 days after last treatment

Population: Data collected and analyzed for patients enrolled in the phase II of the study only.1 Patient did not receive treatment on study and was not evaluable. For each patient that experienced the toxicity, highest grade for that patient is recorded. Grades ranging between 1-5 were collected and are represented below.

Median Overall Survival (OS)

Time frame: From first day of treatment until death from any cause measured, assessed up to 4 years

Population: Patients enrolled in phase II portion of the study were evaluable for OS. One patient in phase II was registered to the study but did not receive treatment and was not evaluable for OS. Two patients did not have death dates and were censored for the last known time to be living.