Clinical trial NCT00002819 (phase 3, status: terminated)
Conditions: ovarian cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: carboplatin, cyclophosphamide, mitoxantrone hydrochloride, paclitaxel
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, ClCCN(CCCl)P1(=O)NCCCO1, OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O, [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
Eligibility criteria:

        DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial
        carcinoma including the following cellular diagnoses: Serous adenocarcinoma Mucinous
        adenocarcinoma Endometrioid adenocarcinoma Clear cell adenocarcinoma Undifferentiated
        carcinoma Mixed epithelial carcinoma Transitional cell carcinoma Malignant Brenner's Tumor
        Stage III (optimal or suboptimal) must be surgically reassessed OR Stage III (suboptimal)
        or stage IV clinically reassessed after induction chemotherapy For stage III surgical
        reassessment: No more than 12 weeks between end of chemotherapy and reassessment surgery
        AND No more than 6 weeks between reassessment surgery and randomization Patients treated on
        protocol GOG-158 are eligible At least a partial response to chemotherapy as defined as:
        Microscopic disease documented at reassessment surgery for patients optimally debulked
        (disease no greater than 1 cm) after primary surgery Suboptimally debulked disease (greater
        than 1 cm) after primary surgery and 1 of the following: Negative reassessment laparotomy
        Only microscopic disease at reassessment surgery Gross residual disease no greater than 1
        cm at reassessment surgery prior to debulking Clinical complete response to induction
        chemotherapy including: - suboptimal disease Stage III or IV AND - either an abnormal CT or
        elevated CA-125 prior to induction chemotherapy and both are within normal limits following
        induction chemotherapy

        PATIENT CHARACTERISTICS: Age: Under 66 Performance status: GOG 0 or 1 Hematopoietic:
        Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic:
        Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times normal Renal: Creatinine
        clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least
        45% by MUGA No congestive heart failure Pulmonary: FEV1 and FVC at least 60% Other: Not
        pregnant or nursing Negative pregnancy test Fertile patients must use effective
        contraception No prior malignancy in the past 5 years except adequately treated
        nonmelanomatous skin cancer, carcinoma in situ of the cervix, or any other cancer whose
        prior treatment does not contraindicate this study

        PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
        Characteristics At least 4 and no more than 6 prior platinum-based combination chemotherapy
        courses (i.e., cisplatin or carboplatin) required Endocrine therapy: Not specified
        Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No prior
        anthracyclines