Clinical trial NCT00692900 (phase 1, status: completed)
Conditions: ovarian cancer, peritoneal cancer, fallopian tube cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02, C57.00, C57.01, C57.02
Drugs: intravenous docetaxel with intraperitoneal oxaliplatin, intravenous oxaliplatin with intraperitoneal docetaxel
SMILES: CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent histologically confirmed platinum-sensitive or platinum-resistant ovarian,
             primary peritoneal, or fallopian tube cancer

          -  Subjects may not have had > 3 prior regimens and must not have had a platinum or
             taxane agent within the past 6 months. Last chemotherapy must have been > 4 weeks
             prior to enrollment. Subjects may not have had prior whole abdomen or pelvic
             radiation. Patients may not have had > 6 cycles of an alkylating agent or > 450 mg/m2
             of doxorubicin.

          -  ECOG Performance Score of ≤2 (Appendix A)

          -  Adequate bone marrow as evidenced by:

               -  Absolute neutrophil count > or equal to 1,500/uL

               -  Hemoglobin > or equal to 8 g/dl

               -  Platelet count > or equal to 100,000/uL

          -  Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL

          -  Adequate hepatic function as evidenced by:

               -  Serum total bilirubin < 1.5 mg/dL

               -  Alk Phos, AST/ALT must be < 3x ULN or <5x ULN if hepatic mets.

               -  AST/ALT < 3X the ULN for the reference lab

          -  Patients must be recovered from both the acute and late effects of any prior surgery,
             radiotherapy or other antineoplastic therapy

          -  Patients or their legal representatives must be able to read, understand and provide
             informed consent to participate in the trial.

          -  Patients of childbearing potential and their partners must agree to use an effective
             form of contraception during the study and for 90 days following the last dose of
             study medication (an effective form of contraception is an oral contraceptive or a
             double barrier method)

        Exclusion Criteria:

          -  Patients with an active infection or with a fever > 101.30 F within 3 days of the
             first scheduled day of protocol treatment

          -  Patients with active extra-abdominal metastases

          -  Patients with active CNS metastases. Patients with stable CNS disease, who have
             undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment
             and who have been on a stable dose of corticosteroids for 3 weeks are eligible for the
             trial

          -  History of prior malignancy within the past 5 years except for curatively treated
             basal cell carcinoma of the skin or cervical intra-epithelial neoplasia

          -  Patients with known hypersensitivity to any of the components of docetaxel or
             oxaliplatin

          -  Patients who received pelvic or abdominal radiotherapy

          -  Patients who are receiving concurrent investigational therapy or who have received
             investigational therapy within 30 days of the first scheduled day of protocol
             treatment (investigational therapy is defined as treatment for which there is
             currently no regulatory authority approved indication)

          -  Peripheral neuropathy ≤ Grade 2

          -  Patients who are pregnant or lactating

          -  Any other medical condition, including mental illness or substance abuse, deemed by
             the Investigator to be likely to interfere with a patient's ability to sign informed
             consent, cooperate and participate in the study, or interfere with the interpretation
             of the results.

          -  History of allogeneic transplant

          -  Known HIV or Hepatitis B or C (active, previously treated or both)