Clinical trial NCT00028743 (phase 3, status: completed)
Conditions: fallopian tube cancer, ovarian cancer, 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: carboplatin, cisplatin, paclitaxel, topotecan hydrochloride
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed stage IIB-IV ovarian epithelial, primary peritoneal, or
             fallopian tube cancer

               -  No borderline ovarian tumors

               -  Residual disease allowed

          -  Fine needle aspiration showing an adenocarcinoma is allowed instead of open or
             true-cut biopsy if the following are true:

               -  Presence of pelvic mass AND

               -  Omental cake or other metastasis larger than 2 cm in the upper abdomen unless
                  proven stage IV disease AND

               -  Serum CA 125/carcinoembryonic antigen ratio at least 25 (if less than 25, a
                  barium enema or colonoscopy and gastroscopy or radiological examination of the
                  stomach should be negative for primary tumor within 6 weeks of study) AND

               -  Normal mammography within 6 weeks of study

        PATIENT CHARACTERISTICS:

        Age:

          -  18 to 75

        Performance status:

          -  ECOG 0-1

        Life expectancy:

          -  At least 12 weeks

        Hematopoietic:

          -  Granulocyte count at least 2,000/mm^3

          -  Platelet count at least 150,000/mm^3

        Hepatic:

          -  Not specified

        Renal:

          -  Creatinine no greater than upper limit of normal

        Cardiovascular:

          -  No clinically relevant atrial or ventricular arrhythmias

          -  No myocardial infarction (MI) within the past 6 months (pretreatment ECG as only
             evidence of MI allowed)

          -  No history of second- or third-degree heart blocks unless pacemaker implanted

          -  History of first-degree heart block allowed

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No complete bowel obstruction

          -  No prior allergic reaction to drugs containing Cremophor EL or compounds chemically
             related to study drugs

          -  No condition that would preclude high-volume saline diuresis

          -  No significant neurologic or psychiatric disorder that would preclude study compliance

          -  No active uncontrolled infection

          -  No neuropathy greater than grade 1

          -  No pre-existing hearing loss greater than grade 1

          -  No other concurrent serious illness or medical condition that would preclude study
             participation

          -  No other malignancy within the past 5 years except adequately treated nonmelanoma skin
             cancer or curatively treated carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No concurrent biological response modifiers or immunotherapy

          -  No concurrent prophylactic colony-stimulating factors (CSFs)

               -  Concurrent therapeutic CSFs allowed

        Chemotherapy:

          -  No prior chemotherapy for ovarian cancer

          -  No other concurrent cytotoxic agents

        Endocrine therapy:

          -  No concurrent anticancer hormonal therapy

        Radiotherapy:

          -  No prior radiotherapy for ovarian cancer

        Surgery:

          -  No more than 6 weeks since prior planned pre-chemotherapy surgery for ovarian cancer

          -  Planned interval debulking allowed

          -  Concurrent second-look surgery allowed

        Other:

          -  No prior non-surgical therapy for ovarian cancer

          -  No other concurrent investigational drug therapy

          -  No other concurrent anticancer treatment

          -  Concurrent enrollment on CAN-NCIC-OV13/EORTC 55971 allowed