Clinical trial NCT02083536 (phase 1, status: withdrawn)
Conditions: ovarian cancer, ovarian carcinoma, recurrent ovarian cancer, recurrent ovarian carcinoma
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: docetaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    study voluntarily stopped by principal investigator due to lack of accrual.
  
Eligibility criteria:

        Inclusion Criteria:

          -  1. Patients must have platinum-resistant disease relapsing within 6 months or less
             from the date of their last cycle of initial adjuvant chemotherapy recurrent
             adenocarcinoma from a primary ovarian, tubal, or peritoneal cancer following
             first-line chemotherapy for metastatic disease. There is no limit on prior number of
             chemotherapy regimens. Patients who have received prior systemic docetaxel and
             platinum-based chemotherapy are eligible

          -  1.1 Patients must have ≥ 1cm measurable disease on imaging studies independent of
             patients having an optional surgical salvage procedure.

          -  2. Patients must have a life expectancy of at least 6 months.

          -  3. Patients must have Karnofsky performance status of ≥ 60 or Gynecology Oncology
             (GOG) performance status of ≤ 2 (see www.GOG.org website).

          -  4. Age 18 - 80 years old

          -  5. Patients must have an adequate bone marrow, renal, and hepatic function:

               -  5.1 WBC: ≥ 3,000 /mcl

               -  5.2 ANC: ≥ 1,500 /mcl

               -  5.3 Platelets: ≥ 100,000 /mcl

               -  5.4 Creatinine: < 2.0 mg/dcl

               -  5.5 Bilirubin: < 1.5x institutional normal value

               -  5.6 LDH, GGT, SGPT (ALT), SGOT (AST), and ALK Phos:< 3x institutional normal
                  value.

          -  6. Ability to understand and the willingness to sign a written informed consent
             document.

        Exclusion Criteria:

          -  1. Patients who have received prior radiotherapy to the chest, whole abdomen, or lower
             extremities above the knees.

          -  2. Patients who have received prior radiation therapy to the head, neck, or lower
             extremities below the knees if greater than 3 years prior to study entry.

          -  3. Evidence of extra-abdominal extension of disease (such as groin nodes, lung,
             supraclavicular nodes, and pleural fluid).

          -  4. Patients may not be receiving any other investigational agents within 4 weeks
             preceding the start of study treatment) or chemotherapy for at least 3 weeks preceding
             the start of study treatment.

          -  5. Patients who have been diagnosed with another prior malignant tumor within 3 years
             of study entry, excluding non-melanoma skin cancer and carcinoma in situ of the
             cervix.

          -  6. Patients with prior history of a severe hypersensitivity reaction to paclitaxel
             (polysorbate 80-Cremophor).

          -  7. Patients with current history of uncontrolled hypertension, angina pectoris, heart
             failure, cardiac dysrhythmias, pericardial disease, cardiomyopathy, or active
             infection.

          -  8. Presence of any medical condition that in the opinion of the investigator deems the
             patient unable to participate.

          -  9. Females of child-bearing potential. It is expected that ovarian cancer patients
             would have had a hysterectomy and/or oophorectomy as part of the original standard of
             care.

          -  10. Patients that are < 18 yrs. of age or > 80 yrs. of age.