Clinical trial NCT00087087 (phase 2, status: completed)
Conditions: ovarian cancer, primary 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: pemetrexed disodium
SMILES: [H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed ovarian epithelial or primary peritoneal cancer

               -  Recurrent or persistent disease

          -  Measurable disease

               -  At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional
                  techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral
                  CT scan

               -  Tumors within a previously irradiated field are considered non-target lesions

          -  Must have received 1 prior platinum-based (carboplatin, cisplatin, or another
             organoplatinum compound) chemotherapy regimen for primary disease

               -  Initial treatment may have included high-dose therapy, consolidation, or extended
                  therapy administered after surgical or non-surgical assessment

               -  Patients who had not received prior paclitaxel may have received a second regimen
                  that included paclitaxel

          -  Platinum-resistant or refractory disease

               -  Treatment-free interval < 6 months after prior platinum-based therapy OR
                  progressed during platinum-based therapy

          -  Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG
             protocol for the same patient population)

        PATIENT CHARACTERISTICS:

        Age

          -  Any age

        Performance status

          -  GOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

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

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 3 times ULN*

          -  AST and ALT ≤ 3 times ULN* NOTE: * ≤ 5 times ULN if due to hepatic metastases

        Renal

          -  Creatinine clearance ≥ 45 mL/min

        Other

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer

          -  No neuropathy (sensory or motor) > grade 1

          -  No active infection requiring antibiotics

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 3 months
             after study treatment

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  One prior noncytotoxic (biologic or cytostatic) regimen allowed for management of
             recurrent or refractory disease, including, but not limited to, the following:

               -  Monoclonal antibodies

               -  Cytokines

               -  Small-molecule inhibitors of signal transduction

          -  At least 3 weeks since prior biologic or immunologic therapy

          -  At least 24 hours since prior growth factors

          -  No concurrent routine colony-stimulating factors

        Chemotherapy

          -  See Disease Characteristics

          -  Recovered from prior chemotherapy

          -  No prior cytotoxic chemotherapy for recurrent or persistent disease, including
             retreatment with initial chemotherapy regimens

          -  No prior pemetrexed disodium

        Endocrine therapy

          -  At least 1 week since prior hormonal therapy for the malignant tumor

          -  Concurrent hormone replacement therapy allowed

        Radiotherapy

          -  See Disease Characteristics

          -  No prior radiotherapy to > 25% of bone marrow

          -  At least 2 weeks since prior radiotherapy and recovered

        Surgery

          -  Recovered from prior surgery

        Other

          -  No prior cancer treatment that would preclude study participation

          -  No non-steroidal anti-inflammatory drugs (NSAIDs) for 2-5 days before, during, and for
             1-2 days after study drug administration

               -  Concurrent low-dose (≤ 325 mg/day) aspirin allowed

          -  At least 3 weeks since other prior therapy for the malignant tumor