Clinical trial NCT00087100 (phase 2, status: completed)
Conditions: endometrial cancer
ICD codes: N85.00, N85.01, N85.02, N99.85
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 endometrial adenocarcinoma

               -  Persistent or recurrent disease

          -  Refractory to curative or standard therapy

          -  Measurable disease

               -  At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional
                  techniques, including 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
                  unless progression is documented or biopsy is obtained to confirm persistence ≥
                  90 days after completion of radiotherapy

          -  Must have received 1 prior chemotherapy regimen for endometrial cancer

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

          -  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

          -  AST and ALT ≤ 3 times upper limit of normal (ULN)*

          -  Alkaline phosphatase ≤ 3 times ULN*

          -  Bilirubin ≤ 1.5 times ULN NOTE: * ≤ 5 times ULN if liver metastases are present

        Renal

          -  Creatinine clearance ≥ 45 mL/min

        Other

          -  Not pregnant

          -  Negative pregnancy test

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

          -  Neuropathy (sensory and motor) ≤ grade 1

          -  No active infection requiring antibiotics

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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  At least 3 weeks since prior biologic or immunologic agents for the malignant tumor

          -  One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent
             disease allowed, including, but not limited to, the following:

               -  Monoclonal antibodies

               -  Cytokines

               -  Small-molecule inhibitors of signal transduction

          -  At least 24 hours since prior growth factors

          -  No concurrent routine colony-stimulating factors

        Chemotherapy

          -  See Disease Characteristics

          -  Recovered from prior chemotherapy

          -  No more than 1 prior cytotoxic chemotherapy regimen with either single or combination
             cytotoxic drug therapy

          -  No prior pemetrexed disodium

        Endocrine therapy

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

          -  Concurrent hormone replacement therapy allowed

        Radiotherapy

          -  See Disease Characteristics

          -  At least 2 weeks since prior radiotherapy and recovered

          -  No prior radiotherapy to ≥ 25% of bone marrow

        Surgery

          -  Recovered from prior surgery

        Other

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

          -  No nonsteroidal anti-inflammatory drugs 2-5 days before, during, and for 1-2 days
             after study drug administration

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

          -  No prior therapy that would contraindicate study participation