Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer
A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma
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.
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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
N/A - N/A
Accepts Healthy Volunteers
David S. Miller, MD, ,
Gynecologic Oncology Group
National Cancer Institute (NCI)
David S. Miller, MD, Study Chair, Simmons Cancer Center