Clinical trial NCT00569673 (phase 2, status: completed)
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, trabectedin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12[C@@H]3SC[C@]4(NCCC5=C4C=C(OC)C(O)=C5)C(=O)OC[C@H](N1[C@@H](O)[C@@H]1CC4=CC(C)=C(OC)C(O)=C4[C@H]2N1C)C1=C2OCOC2=C(C)C(OC(C)=O)=C31
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal
             cavity carcinoma

               -  Recurrent or persistent disease

          -  Measurable disease, defined as at least 1 lesion that can be accurately measured in at
             least 1 dimension (longest dimension to be recorded) ≥ 20 mm by conventional
             techniques or ≥ 10 mm by spiral CT scan

          -  Must have at least 1 "target lesion" to be used to assess response on this protocol as
             defined by RECIST criteria

               -  Tumors within a previously irradiated field will be designated as "non-target"
                  lesions unless progression is documented or a biopsy is obtained to confirm
                  persistence at least 90 days following completion of radiation therapy

          -  Must have had 1 prior platinum-based chemotherapeutic regimen for management of
             primary disease containing carboplatin, cisplatin, or another organoplatinum compound
             and the initial treatment may have included high-dose therapy, consolidation, or
             extended therapy administered after surgical or non-surgical assessment

               -  Patients are allowed, but not required to receive, 2 additional cytotoxic
                  regimens for management of recurrent or persistent disease with no more than 1
                  non-platinum, non-taxane regimen

               -  Patients who have received only 1 prior cytotoxic regimen (platinum-based regimen
                  for management of primary disease), must meet 1 of the following criteria:

                    -  Platinum-free interval of < 12 months

                    -  Progressed during platinum-based therapy

                    -  Persistent disease after a platinum-based therapy

          -  Not eligible for a higher priority GOG protocol (i.e., any active GOG Phase III
             protocol for the same patient population)

        PATIENT CHARACTERISTICS:

          -  GOG performance status (PS) 0-2 or after receiving 1 prior treatment regimen (GOG PS
             0-1 after receiving 2 or more prior regimens)

          -  Platelet count ≥ 100,000/mm³

          -  ANC count ≥ 1,500/mm³

          -  Hemoglobin > 9 g/dL

          -  Creatinine ≤ 1.5 times upper limit normal (ULN)

          -  AST and ALT ≤ 2.5 times ULN

          -  CPK normal

          -  Bilirubin or direct bilirubin normal

          -  Alkaline phosphatase normal

          -  Neuropathy (sensory and motor) ≤ grade 1

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active infection requiring antibiotics (except for uncomplicated UTI)

          -  No other invasive malignancy within the past 5 years, except nonmelanoma skin cancer

          -  No known active liver disease or hepatitis

          -  Willing and able to have a central venous catheter

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from effects of recent surgery, radiotherapy, or chemotherapy

          -  At least 1 week since prior hormonal therapy directed at the malignant tumor

               -  Continuation of hormone replacement therapy allowed

          -  At least 3 weeks since other prior therapy, including biological and immunological
             therapy directed at the tumor

          -  Chimeric or human or humanized monoclonal antibodies must be discontinued for at least
             6 weeks prior to study entry

          -  No investigational therapy within the past 30 days

          -  No prior therapy with docetaxel and/or trabectedin

          -  No radiation to more than 25% of marrow-bearing areas

          -  No prior cancer treatment that contraindicates protocol therapy