Clinical trial NCT00303888 (phase 1, status: terminated)
Conditions: fallopian tube cancer, ovarian cancer, primary peritoneal cavity cancer
ICD codes: C57.00, C57.01, C57.02, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C30.0, Z12.81, D14.0, C14.8, D37.09, Z86.003, Z85.818
Drugs: docetaxel, idronoxil
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, OC1=CC=C(C=C1)C1=CC2=C(OC1)C=C(O)C=C2
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed diagnosis of 1 of the following:

               -  Ovarian epithelial cancer

               -  Fallopian tube cancer

               -  Primary peritoneal cavity cancer

          -  Recurrent advanced disease

               -  Eligible for second-line to fifth-line chemotherapy

               -  Received platinum and taxane combination chemotherapy as first-line treatment
                  with disease recurrence > 6 months after conclusion of therapy

                    -  No demonstrated refractoriness or resistance to weekly docetaxel

          -  Meets 1 of the following criteria:

               -  Doubling of blood levels of CA125 in the past 6 months and CA125 levels ≥ 2 times
                  upper limit of normal (ULN)

               -  Measurable disease defined as ≥ 1 lesion ≥ 20 mm by conventional techniques or ≥
                  10 mm by spiral CT scan

          -  No active CNS metastases

               -  Prior CNS metastases allowed provided they were treated with radiation therapy
                  and disease has been stable for 4 weeks

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance score ≥ 60%

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  Life expectancy ≥ 3 months

          -  Creatinine ≤ 1.5 mg/dL

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

          -  Bilirubin normal

          -  Platelet count > 100,000/mm^3

          -  WBC > 3,000/mm^3

          -  Neutrophil count > 1,500/mm^3

          -  Hemoglobin ≥ 8.0 g/dL

          -  Peripheral neuropathy ≤ grade 1

          -  Relative proportions of AST, ALT, and alkaline phosphatase according 1 to the
             following criteria:

               -  Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times ULN

               -  AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN

               -  AP ≤ 5 times ULN AND AST/ALT normal

          -  No active infection

          -  No concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes,
             hypertension, ischemic heart disease, or congestive heart failure)

          -  No history of chronic active hepatitis or cirrhosis

          -  No history of severe hypersensitivity to docetaxel or other drugs formulated with
             polysorbate 80

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No investigational agents within 4 weeks prior to study entry

          -  Recovered from prior antineoplastic therapy

          -  No other concurrent investigational drugs

          -  No other concurrent chemotherapy, radiotherapy, immunotherapy, or hormonal antitumor
             therapy

               -  Concurrent localized radiation therapy allowed for control of local disease
                  complications (e.g., bone metastases) that do not represent a general progression
                  of the disease status

          -  No concurrent grapefruit or grapefruit juice

          -  No concurrent amifostine