Clinical trial NCT00107341 (phase 2, status: completed)
Conditions: esophageal cancer
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10
Drugs: bortezomib, carboplatin, paclitaxel
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of 1 of the following sites:

               -  Esophagus

               -  Gastroesophageal junction

               -  Gastric cardia

                    -  No greater than 2 cm from the gastroesophageal junction into the stomach

          -  Unresectable, metastatic disease

          -  Not a candidate for potentially curative therapy AND no other more reasonable
             potentially curative conventional therapy exists

          -  At least 1 measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral
             CT scan

          -  No known CNS metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  At least 12 weeks

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Bilirubin normal

          -  AST ≤ 3 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2 times ULN

        Renal

          -  Creatinine ≤ 1.5 times ULN

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for up to 6 months after
             completion of study treatment

          -  No peripheral neuropathy ≥ grade 2

          -  No uncontrolled infection

          -  No chronic debilitating disease

          -  No prior allergic reaction to carboplatin or paclitaxel

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior immunotherapy for recurrent or metastatic disease

          -  No prior biologic therapy for recurrent or metastatic disease

          -  No concurrent prophylactic colony-stimulating factors (filgrastim [G-CSF] or
             sargramostim [GM-CSF])

        Chemotherapy

          -  No prior chemotherapy for recurrent or metastatic disease

          -  Prior chemotherapy in the neoadjuvant or adjuvant setting (after complete resection of
             the original tumor) allowed

          -  Prior combination chemotherapy and radiotherapy allowed provided patient achieved a
             complete response AND the last dose of combination therapy was administered ≥ 6 months
             ago

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Chemotherapy

          -  No prior radiotherapy for recurrent or metastatic disease

          -  Prior radiotherapy in the neoadjuvant or adjuvant setting (after complete resection of
             the original tumor) allowed

          -  No prior radiotherapy to > 25% of bone marrow for locally advanced disease

          -  More than 4 weeks since prior radiotherapy

        Surgery

          -  More than 4 weeks since prior open abdominal exploration (e.g., laparotomy)

          -  More than 2 weeks since prior minimally invasive procedures (e.g., laparoscopy)