Clinical trial NCT00052468 (phase 3, status: completed)
Conditions: fallopian tube cancer, ovarian cancer
ICD codes: C57.00, C57.01, C57.02, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: tcg, tc
SMILES: [H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H], [H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H]
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed diagnosis of one of the following:

               -  Ovarian epithelial cancer

                    -  FIGO stage IA/B G3, IC-IV

               -  Fallopian tube cancer

               -  Extra-ovarian papillary serous tumor

          -  The following are ineligible:

               -  Low malignant-potential ovarian tumors (borderline tumors)

               -  Non-epithelial ovarian tumors

               -  Mixed Mullerian tumors

          -  Must have had definitive surgery within the past 6 weeks

          -  No symptomatic brain metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  At least 6 months

        Hematopoietic

          -  WBC at least 3,000/mm^3 OR

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin greater than 10 mg/dL

        Hepatic

          -  Bilirubin no greater than 2 times upper limit of normal

        Renal

          -  Glomerular filtration rate at least 50 mL/min

        Cardiovascular

          -  No congestive heart failure

          -  No myocardial infarction within the past 6 months

          -  No New York Heart Association class III or IV heart disease

          -  No prior atrial or ventricular arrhythmias

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No prior seizures or central nervous system disorder

          -  No prior severe hypersensitivity reaction to products containing Cremophor EL (e.g.,
             cyclosporine or vitamin K)

          -  No known hypersensitivity to compounds chemically related to carboplatin, gemcitabine,
             or paclitaxel

          -  No preexisting motor or sensory neuropathy greater than grade 1

          -  No other malignancy within the past 5 years except:

               -  Malignancies cured by surgery alone

               -  Carcinoma in situ of the cervix

               -  Adequately treated basal cell skin cancer

          -  No complete bowel obstruction

          -  No other concurrent severe medical condition that would preclude study participation

          -  No dementia or significantly altered mental status that would preclude study
             participation

          -  No concurrent severe active infection

          -  Geographically accessible for treatment and follow-up

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent immunotherapy

        Chemotherapy

          -  No prior chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  No concurrent hormonal therapy except:

               -  Hormone replacement therapy

               -  Antiemetic steroids

        Radiotherapy

          -  No prior radiotherapy

          -  No concurrent radiotherapy

        Surgery

          -  See Disease Characteristics

          -  Recovered from prior surgery

        Other

          -  No other concurrent antineoplastic agents

          -  No other concurrent investigational drugs

          -  No other concurrent clinical trial enrollment