Brief Title
Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer
Official Title
A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma
Brief 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Antitumor activity
Condition
Endometrial Cancer
Intervention
pemetrexed disodium
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
51
Start Date
May 2006
Primary Completion Date
August 2007
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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
David S. Miller, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00087100
Organization ID
GOG-0129O
Secondary IDs
LILLY-H3E-US-JMGT
Responsible Party
Sponsor
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
David S. Miller, MD, Study Chair, Simmons Cancer Center
Verification Date
February 2014