Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients With Locally Advanced or Recurrent Urothelial Malignancy
18 Years
N/A
Both
Bladder Cancer, Urethral Cancer
Trial Information
Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients With Locally Advanced or Recurrent Urothelial Malignancy
OBJECTIVES:
- Determine the overall survival of patients with locally advanced or recurrent carcinoma
of the urothelium treated with neoadjuvant carboplatin, paclitaxel, and gemcitabine
followed by concurrent cisplatin and radiotherapy.
- Determine the feasibility of administering this regimen to these patients.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.
- Determine the response rate (confirmed and unconfirmed) of patients treated with the
neoadjuvant regimen and those treated with the whole regimen.
- Determine the proportion of patients who qualify for concurrent cisplatin and
radiotherapy after receiving the neoadjuvant regimen.
- Determine the potential value of suppressor gene expression analysis (p53 and
retinoblastoma gene) and HER2 expression as indicators of prognosis and/or response in
patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive neoadjuvant chemotherapy comprising paclitaxel IV over 3 hours and
carboplatin IV over 15 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
Treatment repeats every 21 days for a maximum of 3 courses in the absence of disease
progression or unacceptable toxicity.
Within 4-8 weeks after the completion of neoadjuvant chemotherapy, patients receive
cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for a maximum of 2
courses in the absence of disease progression or unacceptable toxicity. Patients also
undergo concurrent radiotherapy 5 days a week for 6 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 4 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary or recurrent invasive carcinoma of the urothelium
- Transitional, squamous, or mixed cell subtypes allowed
- Primary disease site must be the urinary bladder or urethra
- Disease confined to the true pelvis (T2-T4, N0-N3, M0)
- Must meet at least 1 of the following criteria:
- Nodal involvement at or below the level of the bifurcation of the iliac
vessels
- Medically or surgically inoperable
- Patient refused cystectomy
- Measurable or nonmeasurable disease
- Evidence of tumor invasion of the muscularis by cystoscopy and biopsy and detailed
bladder mapping within the past 56 days
- No extrapelvic metastases
- Eligible to receive radiotherapy
- Planned radiotherapy at a SWOG-approved facility
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count at least 1,500/mm^3
- Platelet count at least lower limit of normal
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- SGOT or SGPT no greater than 2.5 times ULN
Renal
- Creatinine clearance at least 60 mL/min OR
- Creatinine no greater than ULN
Gastrointestinal
- No chronic diarrhea
- No malabsorption
- No extensive diverticular disease of the colon
- No inflammatory bowel disease
- No other pre-existing gastrointestinal disorders
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active infections requiring antibiotics
- 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
- No prior chemotherapy for patients with a current diagnosis of advanced bladder
cancer that is also the initial diagnosis
- No prior systemic chemotherapy except adjuvant therapy for recurrent disease
completed more than 6 months ago
- No prior carboplatin
- No prior paclitaxel
- No prior gemcitabine
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No prior pelvic radiotherapy
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Ulka N. Vaishampayan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000271309
NCT ID:
NCT00055835
Start Date:
November 2002
Completion Date:
June 2006
Related Keywords:
- Bladder Cancer
- Urethral Cancer
- recurrent bladder cancer
- stage III bladder cancer
- squamous cell carcinoma of the bladder
- stage II bladder cancer
- recurrent urethral cancer
- urethral cancer associated with invasive bladder cancer
- distal urethral cancer
- proximal urethral cancer
- stage IV bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
- Urethral Neoplasms
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| 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 |
| 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 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| Harrington Cancer Center | Amarillo, Texas 79106 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| 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 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| 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 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
| Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
| Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
| Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| 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 |
| Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
| Puget Sound Oncology Consortium | Seattle, Washington 98109 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| Veterans Affairs Medical Center - Amarillo | Amarillo, Texas 79106 |
| CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
| Texas Tech University Health Sciences Center School of Medicine | Amarillo, Texas 79106 |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
| Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans, Louisiana 70112 |
| Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
| Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
| Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
| NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
| Veterans Affairs Medical Center - Little Rock | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
| Josephine Ford Cancer Center at Henry Ford Health System | Detroit, Michigan 48202 |
| University of Tennessee Cancer Institute at Methodist Central Hospital | Memphis, Tennessee 38104 |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
| Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
| Western New York Urology Associates | Buffalo, New York 14220 |
| Veterans Affairs Medical Center - Chicago Westside Hospital | Chicago, Illinois 60612 |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield, Michigan 48075 |
| UMC Southwest Cancer and Research Center | Lubbock, Texas 79415-3364 |
| Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
| Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk, Virginia 23507 |
