Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00087100

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

2.2

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Drug: pemetrexed disodium	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

51 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Antitumor activity []
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California	United States	90095-1781
2	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois	United States	60521
3	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
4	St. Vincent Indianapolis Hospital	Indianapolis	Indiana	United States	46260
5	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
6	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
7	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
8	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
9	St. John's Regional Health Center	Springfield	Missouri	United States	65804
10	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
11	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
12	Alamance Cancer Center at Alamance Regional Medical Center	Burlington	North Carolina	United States	27216
13	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
14	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
15	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
16	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
17	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
18	Lake/University Ireland Cancer Center	Mentor	Ohio	United States	44060
19	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
20	Cancer Care Associates - Midtown Tulsa	Tulsa	Oklahoma	United States	74104
21	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
22	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
23	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390