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Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pemetrexed disodium
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring recurrent endometrial carcinoma, endometrial adenocarcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA
  • Hinsdale Hematology Oncology Associates
  • CCOP - Carle Cancer Center
  • St. Vincent Indianapolis Hospital
  • Holden Comprehensive Cancer Center at University of Iowa
  • Massachusetts General Hospital
  • West Michigan Cancer Center
  • University of Mississippi Cancer Clinic
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • SUNY Downstate Medical Center
  • Alamance Cancer Center at Alamance Regional Medical Center
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Case Comprehensive Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • Riverside Methodist Hospital Cancer Care
  • David L. Rike Cancer Center at Miami Valley Hospital
  • Lake/University Ireland Cancer Center
  • Oklahoma University Cancer Institute
  • Cancer Care Associates - Midtown Tulsa
  • Rosenfeld Cancer Center at Abington Memorial Hospital
  • Avera Cancer Institute
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Outcomes

Primary Outcome Measures

Antitumor activity
Toxicity

Secondary Outcome Measures

Full Information

First Posted
July 8, 2004
Last Updated
February 12, 2014
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00087100
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
recurrent endometrial carcinoma, endometrial adenocarcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pemetrexed disodium
Primary Outcome Measure Information:
Title
Antitumor activity
Title
Toxicity

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S. Miller, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Hinsdale Hematology Oncology Associates
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
St. Vincent Indianapolis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1002
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
University of Mississippi Cancer Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Alamance Cancer Center at Alamance Regional Medical Center
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27216
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
David L. Rike Cancer Center at Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Lake/University Ireland Cancer Center
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cancer Care Associates - Midtown Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Rosenfeld Cancer Center at Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19804902
Citation
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 Oncology. Gynecol Oncol. 2009 Dec;115(3):443-6. doi: 10.1016/j.ygyno.2009.09.004. Epub 2009 Oct 4.
Results Reference
result

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Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer

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