search
Back to results

Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix

Primary Purpose

Cervical 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 Cervical Cancer focused on measuring cervical squamous cell carcinoma, recurrent cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the cervix Squamous cell or non-squamous cell Recurrent disease Progressive disease 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 disease progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy Not amenable to surgery, radiotherapy, or other therapy Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent squamous cell or non-squamous cell carcinoma of the cervix Chemotherapy administered with primary radiotherapy as a radiosensitizer is not considered a systemic chemotherapy regimen 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 At least 24 hours since prior growth factors 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 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 for 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 for the malignant tumor No nonsteroidal anti-inflammatory drugs for 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

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Doctors Medical Center
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
  • Hinsdale Hematology Oncology Associates
  • CCOP - Kansas City
  • St. John's Regional Health Center
  • Women's Cancer Center - Las Vegas
  • SUNY Downstate Medical Center
  • SUNY Upstate Medical University Hospital
  • Hope A Women's Cancer Center
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Case Comprehensive Cancer Center
  • MetroHealth's Cancer Care Center at MetroHealth Medical Center
  • Hillcrest Cancer Center at Hillcrest Hospital
  • Oklahoma University Medical Center
  • Cancer Care Associates - Midtown Tulsa
  • Williamette Gynecologic Oncology P.C.
  • Rosenfeld Cancer Center at Abington Memorial Hospital
  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • M.D. Anderson Cancer Center at University of Texas
  • Massey Cancer Center at Virginia Commonwealth University

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)
search

1. Study Identification

Unique Protocol Identification Number
NCT00087113
Brief Title
Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix
Official Title
A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231517, IND #40061) In the Treatment Of Recurrent Carcinoma Of The Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
June 2006 (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

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 recurrent cancer of the cervix.
Detailed Description
OBJECTIVES: Determine the antitumor activity of pemetrexed disodium in patients with recurrent carcinoma of the cervix 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 22-60 patients will be accrued for this study within 1-2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
cervical squamous cell carcinoma, recurrent cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer

7. Study Design

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

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 carcinoma of the cervix Squamous cell or non-squamous cell Recurrent disease Progressive disease 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 disease progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy Not amenable to surgery, radiotherapy, or other therapy Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent squamous cell or non-squamous cell carcinoma of the cervix Chemotherapy administered with primary radiotherapy as a radiosensitizer is not considered a systemic chemotherapy regimen 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 At least 24 hours since prior growth factors 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 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 for 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 for the malignant tumor No nonsteroidal anti-inflammatory drugs for 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
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Doctors Medical Center
City
Modesto
State/Province
California
ZIP/Postal Code
95350-4138
Country
United States
Facility Name
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Hinsdale Hematology Oncology Associates
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
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
Women's Cancer Center - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Hope A Women's Cancer Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
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
Country
United States
Facility Name
MetroHealth's Cancer Care Center at MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Hillcrest Cancer Center at Hillcrest Hospital
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Oklahoma University Medical Center
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
Williamette Gynecologic Oncology P.C.
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
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
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
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
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Massey Cancer Center at Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18455781
Citation
Miller DS, Blessing JA, Bodurka DC, Bonebrake AJ, Schorge JO; Gynecologic Oncology Group. Evaluation of pemetrexed (Alimta, LY231514) as second line chemotherapy in persistent or recurrent carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2008 Jul;110(1):65-70. doi: 10.1016/j.ygyno.2008.03.009. Epub 2008 May 5.
Results Reference
result

Learn more about this trial

Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix

We'll reach out to this number within 24 hrs