A Phase I Feasibility Trial of Carboplatin, Paclitaxel, and Gemcitabine in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal Carcinoma
Phase 1
18 Years
80 Years
18 Years
80 Years
Open (Enrolling)
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer
Female
Ovarian Cancer, Primary Peritoneal Cavity Cancer
Trial Information
A Phase I Feasibility Trial of Carboplatin, Paclitaxel, and Gemcitabine in Patients With Previously Untreated Epithelial Ovarian Carcinoma and Primary Peritoneal Carcinoma
OBJECTIVES: I. Determine the feasibility of administering multiple courses of chemotherapy
without excessive dose modification or treatment delay in patients with previously untreated
ovarian epithelial carcinoma or primary peritoneal carcinoma. II. Determine the response
rate (in patients with measurable disease) and progression-free interval in these patients
receiving this treatment.
OUTLINE: This is a feasibility study. On day 1, patients receive paclitaxel as a 3 hour
continuous IV infusion followed by carboplatin as a 30 minute infusion. Gemcitabine is
administered by continuous infusion over 30 minutes on day 1 following carboplatin and on
day 8. In the absence of disease progression or unacceptable toxicity, courses repeat every
21 days for a maximum of 8 courses. Patients are followed every 3 months for 2 years, every
6 months for the next 3 years, and annually thereafter.
PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within
approximately 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed, previously untreated: Stage III or
stage IV ovarian epithelial cancer Stage III or stage IV primary peritoneal cancer
PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: GOG 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal:
Creatinine no greater than 1.5 mg/dL Other: Effective contraception required of fertile
patients No significant infections No other severe medical problems that would subject
patient to undue risk from this protocol No other active malignancy within past 5 years
except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for this or any other malignancy Endocrine therapy: Not specified
Radiotherapy: No prior radiotherapy for this or any other malignancy Surgery: No prior
surgery other than cytoreductive surgery and recovered
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Katherine Y. Look, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Indiana University Melvin and Bren Simon Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000066372
NCT ID:
NCT00003378
Start Date:
August 1998
Completion Date:
Related Keywords:
- Ovarian Cancer
- Primary Peritoneal Cavity Cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- primary peritoneal cavity cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington, District of Columbia 20007 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
| MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
| University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
| CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Cooper Hospital/University Medical Center | Camden, New Jersey 08103 |
| Cancer Center of Albany Medical Center | Albany, New York 12208 |
| State University of New York Health Science Center at Brooklyn | Brooklyn, New York 11203 |
| University of Rochester Cancer Center | Rochester, New York 14642 |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
| Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
| Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
| Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
| University of Washington Medical Center | Seattle, Washington 98195-6043 |
| Tacoma General Hospital | Tacoma, Washington 98405 |
| CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
| Women's Cancer Center | Palo Alto, California 94304 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
| Brookview Research, Inc. | Winston-Salem, North Carolina 27103 |
| Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
| CCOP - Baptist Cancer Institute | Memphis, Tennessee 38117 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbia River Program | Portland, Oregon 97213 |
| CCOP - Evanston | Evanston, Illinois 60201 |
| North Shore University Hospital | Manhasset, New York 11030 |
| Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
| Medicine Branch | Bethesda, Maryland 20892 |
| CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |
| Radiation Oncology Branch | Bethesda, Maryland 20892 |
