Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix
Phase 3
N/A
N/A
N/A
N/A
Not Enrolling
Female
Cervical Cancer
Female
Cervical Cancer
Trial Information
Phase III Randomized Trial of Cisplatin/Paclitaxel Versus Cisplatin/Gemcitabine in Recurrent, Persistent or Metastatic Carcinoma of the Cervix
OBJECTIVES:
- Compare the overall survival, progression-free survival, and objective response rate
(confirmed and unconfirmed, complete and partial) of patients with recurrent,
persistent, or metastatic cervical cancer treated with cisplatin and paclitaxel vs
cisplatin and gemcitabine.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease status at study entry (metastatic vs recurrent vs persistent), prior cisplatin as a
radiosensitizer (yes vs no), and extent of disease (confined to pelvis vs extrapelvic
disease). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 2
hours on day 2.
- Arm II:Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV
over 2 hours on day 1.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this
study within 4 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of primary carcinoma of the cervix, meeting 1 of the following staging
criteria:
- Metastatic (stage IVB)
- Recurrent after prior complete response to primary treatment with surgery or
radiotherapy
- Persistent after surgery or radiotherapy
- Measurable disease
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Creatinine less than upper limit of normal OR
- Creatinine clearance greater than 40 mL/min
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No grade 2 or greater sensory or motor neuropathy
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 6 months since prior single-agent chemotherapy as a radiosensitizer
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 28 days since prior radiotherapy
- No prior radiotherapy to measurable target lesions
- No concurrent palliative radiotherapy
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Other
- No prior systemic therapy
- No other concurrent antitumor therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Harry J. Long, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000285630
NCT ID:
NCT00057928
Start Date:
April 2003
Completion Date:
July 2003
Related Keywords:
- Cervical Cancer
- recurrent cervical cancer
- stage IVB cervical cancer
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| Arizona Cancer Center | Tucson, Arizona 85724 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Chao Family Comprehensive Cancer Center | Orange, California 92868 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
| Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| David Grant Medical Center | Travis Air Force Base, California 94535 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
| St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Columbia River Program | Portland, Oregon 97213 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix, Arizona 85012 |
| Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - West Los Angeles | Los Angeles, California 90073 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
| Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
| Boston Medical Center | Boston, Massachusetts 02118 |
| Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
| Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
| Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
| Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
| Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
| Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
| Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
| Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
| Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Veterans Affairs Medical Center - Houston | Houston, Texas 77030 |
| Texas Tech University Health Science Center | Lubbock, Texas 79415 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
| Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
| Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
| Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
| Eastern Virginia Medical School | Norfolk, Virginia 23507 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| Oregon Cancer Institute | Portland, Oregon 97201-3098 |
| University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
| CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
| Barrett Cancer Center | Cincinnati, Ohio 45267-0502 |
| MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
| Mayo Clinic | Jacksonville, Florida 32224 |
| Western New York Urology Associates | Buffalo, New York 14220 |
| James P. Wilmot Cancer Center at the University of Rochester Medical Center | Rochester, New York 14642 |
