Clinical trial NCT00098878 (phase 3, 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: carboplatin
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal
             cancer*

               -  Stage IC-IV disease

               -  Peritoneal carcinomatosis* (ovarian-type) must not be a mucin-secreting tumor

               -  Stage IC patients must have malignant cells in ascitic fluid or peritoneal
                  washings, tumor on the surface of the ovary, or preoperative capsule rupture
                  NOTE: * Histologic confirmation of a primary source in the ovary is not required.

          -  If biospy is not available, cytology showing an adenocarcinoma is allowed provided the
             following criteria is met:

               -  Patient has a pelvis (ovarian) mass AND all of the following:

                    -  Omental cake or other metastasis is larger than 2 cm in the upper abdomen
                       and/or regional lymph node metastasis irrespective of size OR stage IV
                       disease

                    -  Serum CA 125/CEA ratio > 25 or barium enema (or colonoscopy) and gastroscopy
                       (or radiological examination of the stomach) are negative for the presence
                       of a primary tumor and normal mammography within 6 weeks prior to study
                       randomization

          -  Initial cytoreductive laparotomy or biopsy required within the past 8 weeks

               -  Cytoreductive surgery may or may not have been successful during staging
                  laparotomy

          -  No mixed mesodermal tumors

          -  No borderline ovarian tumors or tumors termed "possibly malignant"

          -  No adenocarcinoma of unknown origin, if histologically confirmed to be a
             mucin-secreting tumor

          -  Considered unsuitable for or unwilling to receive platinum-taxane combination therapy

          -  No concurrent endometrial cancer

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-3

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Bilirubin normal

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 5 times ULN

        Renal

          -  Creatinine clearance ≥ 30 mL/min

               -  Obstructive hydronephrosis as a cause of borderline (i.e., creatinine clearance
                  30-45 mL/min) renal function must be treated before study entry

        Cardiovascular

          -  No hypertension

          -  No ischemic heart disease

          -  No myocardial infarction within the past 6 months

          -  No congestive heart failure

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No symptomatic peripheral neuropathy ≥ grade 2

          -  No uncontrolled infection

          -  No other severe and/or uncontrolled medical condition

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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy

          -  No other concurrent cytotoxic chemotherapy until progressive disease occurs

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy

        Surgery

          -  See Disease Characteristics