Clinical Trial: Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix

This study is currently recruiting patients.

Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
cervical squamous cell carcinoma
recurrent cervical cancer
stage III cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer
 Drug: pemetrexed disodium
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Pemetrexed Disodium in Patients With Recurrent Carcinoma of the Cervix

Further Study Details: 

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.

Eligibility

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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

Endocrine therapy

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

Location and Contact Information


Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
Mack Barnes, MD  205-934-5077 

Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
David Kyle King, MD, FACP  602-239-2413    david.king@baannerhealth.com 

California
      Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange,  California,  92868,  United States; Recruiting
Robert A. Burger, MD  714-456-7971    raburger@uci.edu 

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1740,  United States; Recruiting
Jonathan S. Berek, MD  310-206-5161 

      Women's Cancer Center - Los Gatos, Los Gatos,  California,  95032,  United States; Recruiting
Nick M. Spirtos, MD  408-866-3843    nspirtos@wccenter.com 

Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver,  Colorado,  80010,  United States; Recruiting
Francis J. Major, MD  303-388-4876    francis.major@usoncology.com 

Connecticut
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8028,  United States; Recruiting
Peter E. Schwartz, MD  203-785-4014    peter.schwartz@yale.edu 

Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Stephen Scott Grubbs, MD  302-623-4100 

District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States; Recruiting
G. Scott Rose, MD  202-782-8515    scott.rose@na.amedd.army.mil 

Florida
      H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa,  Florida,  33612-9497,  United States; Recruiting
James V. Fiorica, MD  813-972-8478    fiorica@moffitt.usf.edu 

Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Brian F. Issell, MD  808-586-3015    brian@crch.hawaii.edu 

Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
Kendrith M. Rowland, MD  217-383-4083    kendrith.rowland@carle.com 

      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States; Recruiting
L. Stewart Massad, MD  217-545-8882 

      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
Gershon Y. Locker, MD, FACP  847-570-2518    glocker@enh.org 

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
Lawrence Eric Feldman, MD  312-335-3614 

      Rush University Medical Center, Chicago,  Illinois,  60612-3824,  United States; Recruiting
Howard T. Strassner, MD  312-942-6723 

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Seiko Diane Yamada, MD  773-702-6722    sdyamada@babies.bsd.uchicago.edu 

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States; Recruiting
Katherine Yvonne Look, MD  317-274-8987    klook@iupui.edu 

      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States; Recruiting
Michael W. Method, MD, MPH  574-237-8010    mmethod@mhopc.com 

Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1002,  United States; Recruiting
Joel I. Sorosky, MD  319-356-2015    joel-sorosky@uiowa.edu 

Kentucky
      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0084,  United States; Recruiting
Frederick Ueland, MD  606-257-1613    fredueland@yahoo.com 

Massachusetts
      Cancer Center at Tufts - New England Medical Center, Boston,  Massachusetts,  02111,  United States; Recruiting
Kenneth L. Noller, MD  617-636-2382 

      UMASS Memorial Cancer Center - University Campus, Worcester,  Massachusetts,  01605-2982,  United States; Recruiting
Susan L. Zweizig, MD  508-334-1160    zweizig@ummhc.org 

Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
Kathleen Jo Yost, MD  616-391-1230 

      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
Raymond Sterling Lord, MD  269-373-7488    rlord@wmcc.org 

      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Philip J. Stella, MD  734-712-5237 

Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
Patrick J. Flynn, MD  952-993-1517    patrick.flynn@usoncology.com 

      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905-0001,  United States; Recruiting
Harry J. Long, MD  507-284-2511    long.harry@mayo.edu 

      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Linda F. Carson, MD  612-626-3347    carso001@umn.edu 

Mississippi
      Keesler Medical Center - Keesler Air Force Base, Keesler AFB,  Mississippi,  39534-2576,  United States; Recruiting
John Bomalaski, MD  228-377-6396    john.bomalaski@keesler.af.mil 

      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
James Tate Thigpen, MD  601-984-5590    jthigpen@medicine.umsmed.edu 

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
John Wendall Goodwin, MD  417-269-4520    jwg684@sprg.mercy.net 

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
William T. Stephenson, MD  816-823-0555 

      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
Sara Crowder, MD  573-882-1057    crowders@health.missouri.edu 

      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
David Gardner Mutch, MD  314-362-3181 

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
James A. Mailliard, MD  402-280-4364    jamailliard@mrcc.cc 

New Jersey
      Cancer Institute of New Jersey at the Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States; Recruiting
David P. Warshal, MD  856-342-2185    warshal-david@cooperhealth.edu 

New York
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11790-7775,  United States; Recruiting
Michael L. Pearl, MD  631-444-2774 

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Carol L. Brown, MD  212-639-7659 

      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
Andrew Menzin, MD  516-562-4438    amenzin@nshs.edu 

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
Shashikant B. Lele, MD  716-845-5776    shashi.lele@roswellpark.org 

      SUNY Downstate Medical Center, Brooklyn,  New York,  11203,  United States; Recruiting
Ovadia Abulafia, MD  718-270-2152    ovadia.abulafia@downstate.edu 

North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1065,  United States; Recruiting
Brigitte E. Miller, MD  336-716-6673    bemiller@wfubmc.edu 

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
Daniel L. Clarke-Pearson, MD  919-684-3765 

      Gynecologic Oncology Network, Greenville,  North Carolina,  27858,  United States; Recruiting
Howard David Homesley, MD  252-756-5388    hdh7173@aol.com 

      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7570,  United States; Recruiting
Wesley C. Fowler, MD  919-966-1196    wfowler@med.unc.edu 

Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
Jeffrey McCabe Fowler, MD  614-293-8737 

      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0520,  United States; Recruiting
Nader Husseinzadeh, MD  513-558-8450    nallerhusseinzadeh@uc.edu 

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44124,  United States; Recruiting
Peter Graham Rose, MD  216-444-1712    rosep@ccf.org 

      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106,  United States; Recruiting
Steven E. Waggoner, MD  216-844-5011 

Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Robert S. Mannel, MD  405-271-8787    robert-mannel@ouhsc.edu 

Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Keith S. Lanier, MD  503-216-6260 

Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States; Recruiting
Parviz Hanjani, MD  215-885-0220    phanjani@amh.org 

      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
Mark A. Morgan, MD  215-662-6043 

      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
Nava Siegelmann-Danieli, MD  570-271-6834    nsdanieli@geisinger.edu 

      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States; Recruiting
Michael A. Bookman, MD  215-728-2987    ma_bookman@fccc.edu 

      Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
Norman G. Rosenblum, MD, PhD  215-955-6200 

      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States; Recruiting
George Olt, MD  717-531-8144 

      UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States; Recruiting
Joseph L. Kelley, MD  412-641-5418    jkelley@mail.magee.edu 

Tennessee
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States; Recruiting
Kenneth F. Cofer, MD  865-673-9250 

      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States; Recruiting
Marta Ann Crispens, MD  615-322-2114    marta.crispens@vanderbilt.edu 

Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
Lucas Wong, MD  254-724-1053    lwong@swmail.sw.org 

      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
Charles Levenback, MD  713-745-2563    clevenba@mdanderson.org 

      Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas,  Texas,  75390-9032,  United States; Recruiting
David Scott Miller, MD  214-648-3026    david.miller@utsouthwestern.edu 

      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States; Recruiting
Edward V. Hannigan, MD  409-772-2368    ehanniga@utmb.edu 

Vermont
      Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus, Burlington,  Vermont,  05401,  United States; Recruiting
Cheung Wong, MD  802-847-5110    cheung.wong@vtmednet.org 

Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States; Recruiting
Willie Albert Andersen, MD  434-924-9333 

Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States; Recruiting
Benjamin E. Greer, MD  206-685-2463 

      MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma,  Washington,  98405,  United States; Recruiting
Roger B. Lee, MD  253-403-1029    rogerblee@aol.com 

Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
Anthony Evans, MD, PhD  715-387-5161    evans.anthony@marshfieldclinic.org 

      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6188,  United States; Recruiting
Ellen Hartenbach, MD  608-263-1209 

Australia, New South Wales
      Australia New Zealand Gynaecological Oncology Trials Group, Camperdown,  New South Wales,  1450,  Australia; Recruiting
Michael L. Friedlander, MD, PhD, FRACP  61-2-9562-1450    friedlanderM@sesahs.nsw.gov.au 

Canada, Alberta
      Tom Baker Cancer Centre - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada; Recruiting
Gavin C.E. Stuart, MD  403-944-1721    gavinst@cancerboard.ab.ca 

Japan
      Kagoshima City Hospital, Kagoshima City,  892-8580,  Japan; Recruiting
Masayuki Hatae, MD  81-99-224-2101 

Norway
      Norwegian Radium Hospital, Oslo,  N-0310,  Norway; Recruiting
Gunnar B. Kristensen, MD, PhD  47-22-93-40-00    gunnar.kristensen@klinmed.uio.no 

Study chairs or principal investigators

David Scott Miller, MD,  Study Chair,  Simmons Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000372923; GOG-0127T; LILLY-H3E-US-JMGS; NCT00087113
Record last reviewed:  December 2004
Last Updated:  April 4, 2005
Record first received:  July 8, 2004
ClinicalTrials.gov Identifier:  NCT00087113
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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