Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Objectives

I.  Compare recurrence-free interval, pathologic complete response rate, and 
survival in patients with optimal Stage III ovarian epithelial cancer treated 
with intravenous cisplatin/cyclophosphamide vs. intravenous cisplatin/taxol 
vs. intravenous high-dose carboplatin followed by intravenous 
taxol/intraperitoneal cisplatin.

II.  Compare the toxicities and complications of these three regimens.

III.  Correlate serial serum CA-125 levels with findings at second-look 
laparotomy and recurrence-free interval.

Entry Criteria

Disease Characteristics:

Histologic diagnosis of epithelial ovarian carcinoma of one of
the following histologies:
  Serous adenocarcinoma           Endometrioid adenocarcinoma
  Mucinous adenocarcinoma         Undifferentiated carcinoma
  Clear cell adenocarcinoma       Mixed epithelial carcinoma
  Transitional cell carcinoma     Malignant Brenner tumor
            Adenocarcinoma not otherwise specified

Optimal Stage III disease, i.e., no greater than 1 cm in
diameter following appropriate surgery
  Tissue for histologic evaluation required
  Entry required within 6 weeks of surgery

No ovarian epithelial carcinoma of low malignant potential
(borderline carcinomas)

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy

Surgery:
  Optimum debulking required

Patient Characteristics:

Age:
  Any age

Performance status:
  GOG 0-2

Hematopoietic:
  WBC at least 3,000
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.5 x normal
  SGOT no greater than 3 x normal
  No acute hepatitis

Renal:
  Creatinine clearance at least 50 ml/min

Cardiovascular:
  No CHF
  No unstable angina
  No MI in the past 6 months
  No anticipated intolerance to sinus bradycardia
  No abnormal cardiac conduction:
     Bundle branch block
     Heart block
  No requirement for drugs that affect cardiac conduction:
     Propranolol
     Calcium channel blockers
     Lanoxin

Other:
  No septicemia or severe infection
  No severe GI bleeding
  No condition that will interfere with completion of study or
     follow-up
  No prior or concurrent second malignancy except
     nonmelanomatous skin cancer

Expected Enrollment

209 patients/arm will be entered in order to have 188 patients/arm complete 
therapy and undergo second-look surgery.  As of 9/20/93, accrual to Arm I is 
closed, 290 patients have been entered, and an additional 150 patients will be 
randomized to Arms II and III over 7.5 months.

Outline

Randomized study.

Arm I (closed as of 9/93):  2-Drug Combination Intravenous Chemotherapy.  
Cisplatin, CDDP, NSC-119875; Cyclophosphamide, CTX, NSC-26271.

Arm II:  2-Drug Combination Intravenous Chemotherapy.  CDDP; Taxol, TAX, 
NSC-125973.

Arm III:  Single-Agent Intravenous Chemotherapy followed by 2-Drug Combination 
Intravenous/Intraperitoneal Chemotherapy.  Carboplatin, CBDCA, NSC-241240; 
followed by intravenous TAX; intraperitoneal CDDP.

Gardner GJ, Baser RE, Brady MF, et al.: CA125 regression in ovarian cancer patients treated with intravenous versus intraperitoneal platinum-based chemotherapy: a gynecologic oncology group study. Gynecol Oncol 124 (2): 216-20, 2012.[PUBMED Abstract]

Markman M, Bundy BN, Alberts DS, et al.: Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group. J Clin Oncol 19 (4): 1001-7, 2001.[PUBMED Abstract]

Markman M, Bundy B, Benda J, et al.: Randomized phase 3 study of intravenous (IV) cisplatin (CIS)/paclitaxel (PAC) versus moderately high dose IV carboplatin (CARB) followed by IV PAC and intraperitoneal (IP) CIS in optimal residual ovarian cancer (CC): An intergroup trial (GOG,SWOG, ECOG). [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1392, 361a, 1998.

Alvarez Secord A, Darcy KM, Hutson A, et al.: The regulation of MASPIN expression in epithelial ovarian cancer: association with p53 status, and MASPIN promoter methylation: a gynecologic oncology group study. Gynecol Oncol 123 (2): 314-9, 2011.[PUBMED Abstract]

Hamilton CA, Miller A, Miller C, et al.: 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 122 (3): 521-6, 2011.[PUBMED Abstract]

Farley JH, Tian C, Rose GS, et al.: Race does not impact outcome for advanced ovarian cancer patients treated with cisplatin/paclitaxel: an analysis of Gynecologic Oncology Group trials. Cancer 115 (18): 4210-7, 2009.[PUBMED Abstract]

Jewell EL, Darcy KM, Hutson A, et al.: Association between the N-terminally truncated (DeltaN) p63alpha (DeltaNp63alpha) isoform and debulking status, VEGF expression and progression-free survival in previously untreated, advanced stage epithelial ovarian cancer: A Gynecologic Oncology Group study. Gynecol Oncol 115 (3): 424-9, 2009.[PUBMED Abstract]

Zorn KK, Tian C, McGuire WP, et al.: The prognostic value of pretreatment CA 125 in patients with advanced ovarian carcinoma: a Gynecologic Oncology Group study. Cancer 115 (5): 1028-35, 2009.[PUBMED Abstract]

Havrilesky L, Fleming ND, Miner Z, et al.: Correlations between cell cycle regulatory genes and relationship to ovarian cancer prognosis: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2007 Annual Meeting on Women's Cancer, March 3-7, 2007, San Diego, CA. A-299, 2007.

Secord AA, Darcy KM, Hutson A, et al.: Co-expression of angiogenic markers and associations with prognosis in advanced epithelial ovarian cancer: a Gynecologic Oncology Group study. Gynecol Oncol 106 (1): 221-32, 2007.[PUBMED Abstract]

Winter WE 3rd, Maxwell GL, Tian C, et al.: Prognostic factors for stage III epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol 25 (24): 3621-7, 2007.[PUBMED Abstract]

Alberts DS, Delforge A: Maximizing the delivery of intraperitoneal therapy while minimizing drug toxicity and maintaining quality of life. Semin Oncol 33 (6 Suppl 12): S8-17, 2006.[PUBMED Abstract]

Secord AA, Lee PS, Darcy KM, et al.: Maspin expression in epithelial ovarian cancer and associations with poor prognosis: a Gynecologic Oncology Group study. Gynecol Oncol 101 (3): 390-7, 2006.[PUBMED Abstract]

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 33 (6 Suppl 12): S3-7, 2006.[PUBMED Abstract]

Secord AA, Darcy K, Hutson A, et al.: The role of methylation in the regulation of angiogenic inhibitors in advanced ovarian cancer: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-192, 2006.

Singhal P, Lele S: Intraperitoneal chemotherapy for ovarian cancer: where are we now? J Natl Compr Canc Netw 4 (9): 941-6, 2006.[PUBMED Abstract]

Burger RA, Darcy KM, DiSaia PJ, et al.: Association between serum levels of soluble tumor necrosis factor receptors/CA 125 and disease progression in patients with epithelial ovarian malignancy: a gynecologic oncology group study. Cancer 101 (1): 106-15, 2004.[PUBMED Abstract]

Havrilesky LJ, Alvarez AA, Whitaker R, et al.: Loss of expression of the P16 tumor suppressor gene is more frequent in advanced ovarian cancers lacking P53 mutations. [Abstract] Society of Gynecologic Oncologists 2004 Annual Meeting on Women's Cancer, 7-11 February 2004, San Diego, California. A-814, 2004.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Maurie Markman, MD, Protocol chair (Contact information may not be current)		Ph: 216-445-6888; 800-862-7798

Southwest Oncology Group

Charles Drescher, MD, Protocol chair		Ph: 206-215-3200

Eastern Cooperative Oncology Group

Scott Wadler, MD, Protocol chair (Contact information may not be current)		Ph: 718-904-2754

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