Clinical trial NCT00382811 (phase 3, status: completed)
Conditions: fallopian tube cancer, peritoneal neoplasms, ovarian cancer
ICD codes: C57.00, C57.01, C57.02, K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: phenoxodiol, carboplatin, placebo
SMILES: OC1=CC=C(C=C1)C1=CC2=C(OC1)C=C(O)C=C2, N[C@@H](CCCNC(N)=N)C(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-confirmed ovarian, fallopian, or primary peritoneal carcinoma of
             epithelial origin

          -  Recurrent or persistent advanced disease

          -  Have measurable disease

          -  Undergone at least two courses of therapy with a platinum drug (cisplatin or
             carboplatin) and have responded to the first of those courses of therapy as determined
             by either Response Evaluation Criteria in Solid Tumors (RECIST) or Gynecologic Cancer
             Intergroup (GCIG) criteria

          -  Disease relapse as determined by either RECIST or GCIG criteria within 6 months of
             completion of the second or greater course of platinum therapy using a 2-, 3- or
             4-weekly regimen and platinum-free interval of no greater than 6 months at the time of
             enrollment, being the time taken from the last day of platinum therapy

          -  Any number of previous courses of platinum therapy or non-platinum therapy

          -  Likely to survive at least 3 months

          -  Karnofsky performance score of at least 60%

          -  Have adequate physiological function without evidence of major organ dysfunction as
             evidenced by:

               -  serum creatinine < 1.5 mg/dl

               -  serum transaminase levels ≤ 3 x the upper limit of normal (ULN) for the reference
                  laboratory and

               -  bilirubin level < ULN

          -  Have adequate hematological function defined by:

               -  platelets > 100,000/mm3

               -  white cell counts (WCC) > 3,000/mm3

               -  neutrophils > 1,500/mm3

               -  hemoglobin > 8.0 g/dl

          -  Aged > 18

          -  Be able to understand the risks and benefits of the study and give written informed
             consent to participation.

        Exclusion Criteria:

          -  Patients with mucinous histological type of ovarian cancer

          -  Patients who have failed to show a clinical response (RECIST or GCIG criteria) to at
             least one prior course of platinum therapy

          -  Patients with active infection

          -  Patients with concurrent severe and/or uncontrolled medical disease (e.g.,
             uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure,
             etc.)

          -  Patients with a history of chronic active hepatitis or cirrhosis

          -  Patients with HIV

          -  Patients with active central nervous system (CNS) metastases. Patients with known CNS
             metastases must have received prior radiation therapy, and CNS metastatic disease must
             be stable for 4 weeks.

          -  Patients who have not recovered from the acute effects of any prior anti-neoplastic
             therapy

          -  Patients with known hypersensitivity to platinum drugs that cannot be managed with
             concomitant medication.