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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	any age	NCI	GOG-132 GOG-0132

Objectives

I.  Determine the relative efficacy of cisplatin (CDDP) vs. taxol (TAX) vs. 
CDDP/TAX in women with suboptimal Stage III/IV epithelial ovarian cancer 
following appropriate surgery.

II.  Determine the most favorable regimen in terms of progression-free and 
overall survival.

III.  Compare the incidence of ototoxicity and other toxicities arising from 
any of these three regimens.

Entry Criteria

Disease Characteristics:

Histologically confirmed, primary, Stage III/IV ovarian
epithelial cancer of one of the following histologies:
  Serous adenocarcinoma        Undifferentiated carcinoma
  Mucinous adenocarcinoma      Mixed epithelial carcinoma
  Clear cell adenocarcinoma    Malignant Brenner's tumor
  Endometrioid adenocarcinoma  Transitional cell carcinoma
  Adenocarcinoma - NOS

Disease must be suboptimal (greater than 1 cm in diameter)
following appropriate surgery (at a minimum, exploratory
laparotomy)
  Protocol entry within 6 weeks of surgery required

Measurable disease preferred but not required

Cytologic confirmation required if malignant pleural effusion
is the sole disease manifestation

No borderline carcinoma

No unclassified ovarian cancer (i.e., patient not explored or
verification of ovarian stromal origin not possible)

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior cytotoxic chemotherapy for cancer

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy

Surgery:
  Exploratory laparotomy and appropriate surgical debulking
  required within 6 weeks of entry

Patient Characteristics:

Age:
  Any age

Performance status:
  GOG 0-2

Hematopoietic:
  WBC at least 3,000
  AGC at least 1,500
  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 no greater than 2.0 mg/dl

Cardiovascular:
  No history of CHF
  No unstable angina
  No MI within the past 6 months
  No history of arrhythmia or requirement for antiarrhythmic
     agents

Other:
  No septicemia or severe infection
  No severe GI bleeding
  No prior or concomitant second malignancy except
     nonmelanomatous skin cancer

Expected Enrollment

600 patients will be accrued over an estimated 30 months.  After 50 failures 
are reported on Arm I, progression-free survival will be assessed; if at least 
1 of the single-agent arms is clearly inferior to the combination arm, accrual 
to the least effective arm will cease.

Outline

Randomized study.

Arm I:  Single-agent Chemotherapy.  Cisplatin, CDDP, NSC-119875.

Arm II:  Single-agent Chemotherapy.  Taxol, TAX, NSC-125973.

Arm III:  2-Drug Combination Chemotherapy.  CDDP; TAX.

Muggia FM, Braly PS, Brady MF, et al.: Phase III randomized study of cisplatin versus paclitaxel versus cisplatin and paclitaxel in patients with suboptimal stage III or IV ovarian cancer: a gynecologic oncology group study. J Clin Oncol 18 (1): 106-15, 2000.[PUBMED Abstract]

Muggia FM, Braly PS, Brady MF, et al.: Phase III of cisplatin (P) or paclitaxel (T), versus their combination in suboptimal stage III and IV epithelial ovarian cancer (EOC): Gynecologic Oncology Group (GOG) study #132. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A-1257, 352a, 1997.

Colombo N, Parma G, Bocciolone L, et al.: Medical therapy of advanced malignant epithelial tumours of the ovary. Forum (Genova) 10 (4): 323-32, 2000 Oct-Dec.[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]

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.

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.

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 : , 2009.[PUBMED Abstract]

Moss C, Kaye SB: Ovarian cancer: progress and continuing controversies in management. Eur J Cancer 38 (13): 1701-7, 2002.[PUBMED Abstract]

Muggia FM: Sequential single agents as first-line chemotherapy for ovarian cancer: a strategy derived from the results of GOG-132. Int J Gynecol Cancer 13 (Suppl 2): 156-62, 2003 Nov-Dec.[PUBMED Abstract]

Sandercock J, Parmar MK, Torri V: First-line chemotherapy for advanced ovarian cancer: paclitaxel, cisplatin and the evidence. Br J Cancer 78 (11): 1471-8, 1998.[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.

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]

Winter WE 3rd, Maxwell GL, Tian C, et al.: Tumor residual after surgical cytoreduction in prediction of clinical outcome in stage IV epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol 26 (1): 83-9, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Franco Muggia, MD, Protocol chair		Ph: 212-263-6485 Email: muggif01@gcrc.med.nyu.edu

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