Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GOG-0126L |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1 and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| gemcitabine hydrochloride | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed primary ovarian epithelial cancer or primary peritoneal carcinoma
Bidimensionally measurable disease by physical examination or medical imaging techniques
Must not be eligible for a higher priority Gynecologic Oncology Group protocol
Must have received one, and only one, prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
Platinum-resistant or refractory (i.e., treatment-free interval after platinum-based therapy of less than 6 months or progressed during platinum-based therapy)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cheryl A. Brewer, MD | University of Illinois College of Medicine at Peoria | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Hospital of Los Gatos | Los Gatos | California | 95032 | United States | ||
| H. Lee Moffitt Cancer Center and Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16643994 | Result | Brewer CA, Blessing JA, Nagourney RA, Morgan M, Hanjani P. Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Nov;103(2):446-50. doi: 10.1016/j.ygyno.2006.03.018. Epub 2006 Apr 27. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tampa |
| Florida |
| 33612-9497 |
| United States |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | 60612-3864 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Ellis Fischel Cancer Center | Indianapolis | Indiana | 46285 | United States |
| Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242-1009 | United States |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland | 20892-1182 | United States |
| Tuft-New England Medical Center | Boston | Massachusetts | 02111 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Ellis Fischel Cancer Center - Columbia | Columbia | Missouri | 65203 | United States |
| Cooper Hospital/University Medical Center | Camden | New Jersey | 08103-1489 | United States |
| State University of New York Health Science Center at Brooklyn | Brooklyn | New York | 11203 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York | 11794-8091 | United States |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | 27599-7295 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1065 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| University of Oklahoma College of Medicine | Oklahoma City | Oklahoma | 73190 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001-3788 | United States |
| Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104-4283 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Brookview Research, Inc. | Nashville | Tennessee | 37203 | United States |
| Simmons Cancer Center - Dallas | Dallas | Texas | 75390-9032 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0587 | United States |
| CCOP - M.D. Anderson Research Base | Houston | Texas | 77030-4009 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792-6188 | United States |
| Norwegian Radium Hospital | Oslo | N-0310 | Norway |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided