Clinical trial NCT00666991 (phase 1, status: completed)
Conditions: peritoneal neoplasms
ICD codes: K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02
Drugs: nanoparticulate paclitaxel
SMILES: [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:

        Inclusion Criteria:

          -  Patients must be at least 18 years of age.

          -  Patients must have histologic or cytologic diagnosis of carcinoma predominantly
             confined to the peritoneal cavity.

          -  Patients must have failed all potentially curative therapy and have no other systemic
             treatment options available for extra-peritoneal disease. Patients with ovarian cancer
             that are platinum sensitive must have failed primary and at least one salvage regimen.
             Patients may undergo surgical debulking prior to entry into the trial.

          -  At least 28 days must have elapsed since completion of any other previous chemotherapy
             treatment received prior to registration in this study.

          -  Patients may have received prior abdominal surgery greater than 2 weeks prior to
             registration. Patients must have recovered from all effects of the surgical procedure.

          -  Patients must have a Zubrod Performance Status of 0 - 2.

          -  Patients must have a pretreatment granulocyte count greater than or equal to
             1,500/microliter and platelet count greater than or equal to 100,000/microliter
             obtained within 14 days prior to registration.

          -  Patients must have adequate renal function as documented by a serum creatinine less
             than or equal to 1.5 times the institutional upper limit of normal obtained within 14
             days prior to registration.

          -  Patients must have adequate hepatic function as documented by a bilirubin of less than
             or equal to 2 times the institutional upper limit of normal and an SGOT less than 5
             times the institutional upper limit of normal obtained within 14 days prior to
             registration. Patients with hepatobiliary stents are eligible for this trial if the
             bilirubin meets the above parameter.

          -  There should be no plans for the patient to receive concomitant radiation therapy,
             hormonal therapy, or other chemotherapy for their tumor while on this protocol.

        Exclusion Criteria:

          -  Patients with active inflammatory bowel disease or chronic diarrhea

          -  Patients with uncontrolled hypertension, unstable angina, symptomatic congestive heart
             failure, myocardial infarction within previous 6 months or serious uncontrolled
             cardiac arrhythmia

          -  Patients with active infection requiring systemic therapy

          -  Pregnant or nursing women

          -  Patients with Grade 2 or greater sensory neuropathy (by NCI Common Toxicity Criteria)
             at the time of study registration

          -  Patients taking concomitant medications demonstrated to inhibit or induce CYP3A4 or
             CYP2C8

          -  Patients with pre-existing conditions that prohibit the use of intravenous
             dexamethasone at the recommended dose