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A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma

Phase 2
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma


- 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

Inclusion Criteria


- 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)



- Any age

Performance status

- GOG 0-2

Life expectancy

- Not specified


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

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL


- 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


- Creatinine clearance ≥ 45 mL/min


- 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


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


- 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


- See Disease Characteristics

- At least 2 weeks since prior radiotherapy and recovered

- No prior radiotherapy to ≥ 25% of bone marrow


- Recovered from prior surgery


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:


Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2006

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • endometrial adenocarcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
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