Patient case: 58-year-old female with endometrial cancer; genetic feature: PIK3R1

Clinical trial: Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer

Summary: RATIONALE: Drugs used in chemotherapy such as pemetrexed disodium work in different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with persistent or recurrent endometrial cancer.

Detailed description: OBJECTIVES:
  -  Determine the antitumor activity of pemetrexed disodium in patients with persistent or recurrent endometrial adenocarcinoma that failed higher priority treatment protocols.
  -  Determine the nature and degree of toxicity of this drug in these patients.
  OUTLINE: This is a multicenter study.
  Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.
  Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
  PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 1-3.4 years.

Eligibility: 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

Relevance to patient case: not relevant