Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087100
• Other study ID #: GOG-0129O
• Secondary ID: LILLY-H3E-US-JMG
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2004
• Last updated: February 12, 2014
• Start date: May 2006

Study information

• Verified date: February 2014
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer

Intervention

Drug:
• pemetrexed disodium

Locations

Country	Name	City	State
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Alamance Cancer Center at Alamance Regional Medical Center	Burlington	North Carolina
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	St. Vincent Indianapolis Hospital	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	Lake/University Ireland Cancer Center	Mentor	Ohio
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Cancer Care Associates - Midtown Tulsa	Tulsa	Oklahoma
United States	CCOP - Carle Cancer Center	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Miller DS, Blessing JA, Drake RD, Higgins R, McMeekin DS, Puneky LV, Krasner CN. A phase II evaluation of pemetrexed (Alimta, LY231514, IND #40061) in the treatment of recurrent or persistent endometrial carcinoma: a phase II study of the Gynecologic Onco — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumor activity			No
Primary	Toxicity			Yes