Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer
Study Details
Study Description
Brief Summary
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 and giving drugs in different ways may kill more tumor cells. It is not yet known whether intravenous two-drug combination chemotherapy is more effective than intravenous and intraperitoneal infusions of three-drug combination chemotherapy for treating primary peritoneal or stage III epithelial ovarian cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous two-drug combination chemotherapy with intravenous and intraperitoneal three-drug combination chemotherapy in treating patients who have primary peritoneal or stage III epithelial ovarian cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
OBJECTIVES: I. Compare pathological response, recurrence-free interval, and survival in patients with optimal stage III epithelial ovarian cancer or primary peritoneal carcinoma receiving intravenous (IV) paclitaxel and cisplatin vs IV paclitaxel and intraperitoneal (IP) cisplatin plus IP paclitaxel. II. Compare the toxic effects and complications of these 2 treatment regimens in these patients. III. Determine the frequency and prognostic significance of BRCA1 and BRCA2 mutations in these patients. IV. Determine the effect of non-genetic risk factors on the course of disease in BRCA1- and BRCA2-related ovarian cancer or primary peritoneal carcinoma. V. Compare the quality of life of these patients receiving these treatments.
OUTLINE: This is a randomized study. Patients are stratified according to gross residual disease (present vs absent) and whether second-look surgery will be performed at the end of treatment (yes vs no). Blood is drawn for BRCA mutation analysis and DNA extraction before the start of chemotherapy, but after randomization. Patients are randomized to one of two treatment arms. Patients in arm I receive IV paclitaxel by 24-hour infusion on day 1 followed by IV cisplatin on day 2. Patients in arm II receive IV paclitaxel by 24-hour infusion on day 1 followed by intraperitoneal (IP) cisplatin on day 2, plus IP paclitaxel on day 8. Treatment for both arms repeats every 3 weeks for a total of 6 treatment courses. Following chemotherapy, second look surgery is performed if selected by the patient. Quality-of-life assessments are performed prior to randomization, prior to course 4, 3-6 weeks after the completion of course 6 and prior to second look surgery if selected, 6 months after treatment is completed, and 12 months after treatment is completed. Patients are followed every 3 months for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 384 patients will be accrued for this study within 16 months.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS: Histologically proven primary peritoneal carcinoma or optimal (no greater than 1 cm residual disease) stage III epithelial ovarian carcinoma with the following epithelial cell types: Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell carcinoma Malignant Brenner's Tumor Adenocarcinoma NOS Prior surgery for ovarian/peritoneal carcinoma required No epithelial ovarian carcinoma of low malignant potential (borderline carcinoma)
PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal No acute hepatitis Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No unstable angina No myocardial infarction within prior 6 months Patients with abnormal cardiac conduction are eligible if disease stable for at least 6 months Other: No septicemia or severe infection No severe gastrointestinal bleeding No other invasive malignancy within past 5 years except nonmelanoma skin cancer Any previous cancer treatment must not contraindicate this protocol therapy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No more than 6 weeks since prior surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Comprehensive Cancer Center | Birmingham | Alabama | United States | 35294 |
| 2 | CCOP - Greater Phoenix | Phoenix | Arizona | United States | 85006-2726 |
| 3 | USC/Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033-0800 |
| 4 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1781 |
| 5 | Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
| 6 | Women's Cancer Center | Palo Alto | California | United States | 94304 |
| 7 | University of Colorado Cancer Center | Denver | Colorado | United States | 80262 |
| 8 | Lombardi Cancer Center, Georgetown University | Washington | District of Columbia | United States | 20007 |
| 9 | Walter Reed Army Medical Center | Washington | District of Columbia | United States | 20307-5000 |
| 10 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
| 11 | Emory University Hospital - Atlanta | Atlanta | Georgia | United States | 30322 |
| 12 | CCOP - Atlanta Regional | Atlanta | Georgia | United States | 30342-1701 |
| 13 | MBCCOP - Hawaii | Honolulu | Hawaii | United States | 96813 |
| 14 | Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | United States | 60612 |
| 15 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60637 |
| 16 | CCOP - Central Illinois | Decatur | Illinois | United States | 62526 |
| 17 | CCOP - Evanston | Evanston | Illinois | United States | 60201 |
| 18 | Indiana University Cancer Center | Indianapolis | Indiana | United States | 46202-5265 |
| 19 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 20 | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | United States | 40536-0084 |
| 21 | Johns Hopkins Oncology Center | Baltimore | Maryland | United States | 21231 |
| 22 | Medicine Branch | Bethesda | Maryland | United States | 20892 |
| 23 | Radiation Oncology Branch | Bethesda | Maryland | United States | 20892 |
| 24 | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | United States | 01655 |
| 25 | CCOP - Ann Arbor Regional | Ann Arbor | Michigan | United States | 48106 |
| 26 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 27 | University of Minnesota Cancer Center | Minneapolis | Minnesota | United States | 55455 |
| 28 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
| 29 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
| 30 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 31 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
| 32 | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | United States | 68131 |
| 33 | CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
| 34 | Cooper Hospital/University Medical Center | Camden | New Jersey | United States | 08103 |
| 35 | St. Barnabas Medical Center | Livingston | New Jersey | United States | 07039 |
| 36 | Morristown Memorial Hospital | Morristown | New Jersey | United States | 07962-1956 |
| 37 | Cancer Center of Albany Medical Center | Albany | New York | United States | 12208 |
| 38 | State University of New York Health Science Center at Brooklyn | Brooklyn | New York | United States | 11203 |
| 39 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 40 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
| 41 | University of Rochester Cancer Center | Rochester | New York | United States | 14642 |
| 42 | State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York | United States | 11790-7775 |
| 43 | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | United States | 27599-7295 |
| 44 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
| 45 | Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | United States | 27157-1082 |
| 46 | Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | United States | 45219 |
| 47 | Ireland Cancer Center | Cleveland | Ohio | United States | 44106-5065 |
| 48 | Cleveland Clinic Cancer Center | Cleveland | Ohio | United States | 44195 |
| 49 | Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | United States | 43210 |
| 50 | University of Oklahoma College of Medicine | Oklahoma City | Oklahoma | United States | 73190 |
| 51 | CCOP - Sooner State | Tulsa | Oklahoma | United States | 74136 |
| 52 | CCOP - Columbia River Program | Portland | Oregon | United States | 97213 |
| 53 | Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
| 54 | Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 55 | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | United States | 19104 |
| 56 | Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | United States | 19107 |
| 57 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 58 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425-0721 |
| 59 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
| 60 | CCOP - Baptist Cancer Institute | Memphis | Tennessee | United States | 38117 |
| 61 | Brookview Research, Inc. | Nashville | Tennessee | United States | 37203 |
| 62 | Simmons Cancer Center - Dallas | Dallas | Texas | United States | 75235-9154 |
| 63 | University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 64 | Cancer Center, University of Virginia HSC | Charlottesville | Virginia | United States | 22908 |
| 65 | University of Washington Medical Center | Seattle | Washington | United States | 98195-6043 |
| 66 | Tacoma General Hospital | Tacoma | Washington | United States | 98405 |
| 67 | Tom Baker Cancer Center - Calgary | Calgary | Alberta | Canada | T2N 4N2 |
Sponsors and Collaborators
- Gynecologic Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Deborah K. Armstrong, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Documents (Full-Text)
None provided.More Information
Publications
- Alberts DS, Delforge A. Maximizing the delivery of intraperitoneal therapy while minimizing drug toxicity and maintaining quality of life. Semin Oncol. 2006 Dec;33(6 Suppl 12):S8-17. Review.
- Aletti GD, Nordquist D, Hartmann L, Gallenberg M, Long HJ, Cliby WA. From randomized trial to practice: single institution experience using the GOG 172 i.p. chemotherapy regimen for ovarian cancer. Ann Oncol. 2010 Sep;21(9):1772-1778. doi: 10.1093/annonc/mdq025. Epub 2010 Feb 5.
- Armstrong DK, Brady MF. Intraperitoneal therapy for ovarian cancer: a treatment ready for prime time. J Clin Oncol. 2006 Oct 1;24(28):4531-3.
- Barlin JN, Dao F, Bou Zgheib N, Ferguson SE, Sabbatini PJ, Hensley ML, Bell-McGuinn KM, Konner J, Tew WP, Aghajanian C, Chi DS. Progression-free and overall survival of a modified outpatient regimen of primary intravenous/intraperitoneal paclitaxel and intraperitoneal cisplatin in ovarian, fallopian tube, and primary peritoneal cancer. Gynecol Oncol. 2012 Jun;125(3):621-4. doi: 10.1016/j.ygyno.2012.03.027. Epub 2012 Mar 21.
- Baysal BE, DeLoia JA, Willett-Brozick JE, Goodman MT, Brady MF, Modugno F, Lynch HT, Conley YP, Watson P, Gallion HH. Analysis of CHEK2 gene for ovarian cancer susceptibility. Gynecol Oncol. 2004 Oct;95(1):62-9.
- Bristow RE, Santillan A, Salani R, Diaz-Montes TP, Giuntoli RL 2nd, Meisner BC, Armstrong DK, Frick KD. Intraperitoneal cisplatin and paclitaxel versus intravenous carboplatin and paclitaxel chemotherapy for Stage III ovarian cancer: a cost-effectiveness analysis. Gynecol Oncol. 2007 Sep;106(3):476-81. Epub 2007 Aug 3.
- Darcy KM, Tian C, Ambrosone CB, et al.: A Gynecologic Oncology Group study of associations between polymorphisms in ABC transporter genes (ABCB1, ABCC2, and ABCG2) and outcome in advanced stage epithelial ovarian cancer treated with platinum and taxane chemotherapy. [Abstract] J Clin Oncol 27 (Suppl 15): A-5567, 2009.
- Farley JH, Tian C, Rose GS, Brown CL, Birrer M, Maxwell GL. Race does not impact outcome for advanced ovarian cancer patients treated with cisplatin/paclitaxel: an analysis of Gynecologic Oncology Group trials. Cancer. 2009 Sep 15;115(18):4210-7. doi: 10.1002/cncr.24482.
- Hamilton CA, Miller A, Miller C, Krivak TC, Farley JH, Chernofsky MR, Stany MP, Rose GS, Markman M, Ozols RF, Armstrong DK, Maxwell GL. The impact of disease distribution on survival in patients with stage III epithelial ovarian cancer cytoreduced to microscopic residual: a Gynecologic Oncology Group study. Gynecol Oncol. 2011 Sep;122(3):521-6. doi: 10.1016/j.ygyno.2011.04.041. Epub 2011 Jun 17.
- Havrilesky LJ, Secord AA, Darcy KM, Armstrong DK, Kulasingam S; Gynecologic Oncology Group. Cost effectiveness of intraperitoneal compared with intravenous chemotherapy for women with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2008 Sep 1;26(25):4144-50. doi: 10.1200/JCO.2007.13.1961.
- Markman M. Clinical efficacy supporting the role of intraperitoneal drug delivery in the primary chemotherapeutic management of small-volume residual advanced ovarian cancer. Semin Oncol. 2006 Dec;33(6 Suppl 12):S3-7. Review.
- Rubatt JM, Darcy KM, Tian C, Muggia F, Dhir R, Armstrong DK, Bookman MA, Niedernhofer LJ, Deloia J, Birrer M, Krivak TC. Pre-treatment tumor expression of ERCC1 in women with advanced stage epithelial ovarian cancer is not predictive of clinical outcomes: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 May;125(2):421-6. doi: 10.1016/j.ygyno.2012.01.008. Epub 2012 Jan 16.
- Singhal P, Lele S. Intraperitoneal chemotherapy for ovarian cancer: where are we now? J Natl Compr Canc Netw. 2006 Oct;4(9):941-6. Review.
- Tian C, Ambrosone CB, Darcy KM, Krivak TC, Armstrong DK, Bookman MA, Davis W, Zhao H, Moysich K, Gallion H, DeLoia JA. Common variants in ABCB1, ABCC2 and ABCG2 genes and clinical outcomes among women with advanced stage ovarian cancer treated with platinum and taxane-based chemotherapy: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 Mar;124(3):575-81. doi: 10.1016/j.ygyno.2011.11.022. Epub 2011 Nov 21.
- von Gruenigen VE, Huang HQ, Gil KM, Gibbons HE, Monk BJ, Rose PG, Armstrong DK, Cella D, Wenzel L. A comparison of quality-of-life domains and clinical factors in ovarian cancer patients: a Gynecologic Oncology Group study. J Pain Symptom Manage. 2010 May;39(5):839-46. doi: 10.1016/j.jpainsymman.2009.09.022.
- Winter WE 3rd, Maxwell GL, Tian C, Carlson JW, Ozols RF, Rose PG, Markman M, Armstrong DK, Muggia F, McGuire WP; Gynecologic Oncology Group Study. Prognostic factors for stage III epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Aug 20;25(24):3621-7.
- Zorn KK, Tian C, McGuire WP, Hoskins WJ, Markman M, Muggia FM, Rose PG, Ozols RF, Spriggs D, Armstrong DK. The prognostic value of pretreatment CA 125 in patients with advanced ovarian carcinoma: a Gynecologic Oncology Group study. Cancer. 2009 Mar 1;115(5):1028-35. doi: 10.1002/cncr.24084.
- CDR0000066273
- GOG-0172