Clinical trial NCT00043082 (phase 3, status: completed)
Conditions: ovarian cancer, peritoneal cavity cancer
ICD codes: 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, pegylated liposomal doxorubicin hydrochloride
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed ovarian epithelial carcinoma

               -  Stage III or IV disease at time of initial staging laparotomy

          -  Primary peritoneal and mixed Mullerian tumors allowed

          -  No borderline ovarian tumors

          -  Disease progression or recurrence after a progression-free and platinum-free interval
             of 6-24 months after completion of first-line platinum-based chemotherapy (either
             single agent or combination therapy)

          -  Disease progression or recurrence based solely on CA 125 elevation allowed, provided
             that one of the following is true:

               -  Prior baseline CA 125 greater than 35 U/mL and subsequent normalization of no
                  greater than 35 U/mL must have CA 125 greater than 2 times upper limit of normal
                  (ULN) on 2 occasions at least 1 week apart

               -  Prior baseline CA 125 greater than 35 U/mL that never normalized must have CA 125
                  greater than 2 times the nadir value on 2 occasions at least 1 week apart

               -  Prior normal baseline CA 125 (no greater than 35 U/mL) must show CA 125 greater
                  than 2 times ULN on 2 occasions at least 1 week apart

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

        Age

          -  Not specified

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

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

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

          -  Hemoglobin at least 10 g/dL

        Hepatic

          -  SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN)

          -  Alkaline phosphatase no greater than 2 times ULN

          -  Bilirubin no greater than ULN

        Renal

          -  Creatinine no greater than 1.9 mg/dL

        Cardiovascular

          -  No New York Heart Association class II-IV cardiac disease

          -  No clinical evidence of congestive heart failure

          -  Ejection fraction greater than 50% by MUGA or 2-dimensional echocardiogram

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid
             cancer

          -  No evidence of active or uncontrolled infection

          -  No severe gastrointestinal symptoms (i.e., partial obstruction) and/or
             gastrointestinal bleeding or diarrhea

          -  No greater than grade 1 preexisting sensory neuropathy

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  At least 28 days since prior biologic consolidation therapy

          -  No concurrent immunotherapy

        Chemotherapy

          -  See Disease Characteristics

          -  At least 28 days since prior non-platinum-containing consolidation chemotherapy

          -  No prior pegylated doxorubicin HCl liposome

          -  No prior cumulative anthracycline (e.g., doxorubicin, daunorubicin, epirubicin) dose
             in excess of 240 mg/m^2

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  No concurrent hormonal therapy

        Radiotherapy

          -  No prior abdominopelvic irradiation

          -  No concurrent radiotherapy

        Surgery

          -  See Disease Characteristics

          -  At least 28 days since prior surgical debulking for disease progression or recurrence
             and recovered

          -  No concurrent surgery

        Other

          -  No other prior treatment during the 6-24 month progression-free and platinum-free
             interval except up to 12 courses of consolidation therapy

          -  No other concurrent anticancer therapy