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

Basic Trial Information

Objectives

I.  Compare response rate, response duration, and survival of patients with 
suboptimal Stage III and Stage IV ovarian carcinoma randomly assigned to 
treatment with cisplatin/taxol vs. cisplatin/cyclophosphamide.
II.  Further evaluate the toxicities of cisplatin/taxol in this patient 
population.
III.  Compare the therapeutic index of these two combinations in patients with 
ovarian carcinoma.

Entry Criteria

Disease Characteristics:

Histologically documented suboptimal Stage III (i.e., greater
than 1 cm in diameter) or Stage IV epithelial ovarian carcinoma

The following histologies are acceptable:
  Serous adenocarcinoma
  Mucinous adenocarcinoma
  Clear cell adenocarcinoma
  Endometrioid adenocarcinoma
  Undifferentiated carcinoma
  Mixed epithelial carcinoma

Borderline carcinoma and "probably malignant" tumors are
excluded

Measurable disease preferred but not required

  Cytologic confirmation required if entry is based on
  malignant pleural effusion (35 mm slide of cytology specimen
  must be submitted)

  Postoperative CT scan required and report available at
  randomization for patients with nonmeasurable disease

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy

Surgery:
  No more than 6 weeks beyond optimal surgery for ovarian
  cancer consisting minimally of exploratory laparotomy with
  biopsy and, when appropriate, TAH/BSO

Patient Characteristics:

Age:
  18 and over

Performance status:
  GOG 0-2

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

Hepatic:
  Bilirubin no more than 2 x normal
  SGOT no more than 2 x normal
  No acute hepatitis

Renal:
  Creatinine no more than 2.0 mg/dl

Cardiovascular:
  No current requirement for anti-arrhythmic medication
  No history of cardiac arrhythmia

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

Expected Enrollment

It is estimated that a total of 360 patients will be entered over about 2.5 
years.

Outline

Randomized study.
Arm I:  2-Drug Combination Chemotherapy.  Cisplatin, CACP, NSC-119875; 
Cyclophosphamide, CTX, NSC-26271.
Arm II:  2-Drug Combination Chemotherapy.  CACP; Taxol, TAX, NSC-125973.

Hill E, Brady W, Birrer MJ, et al.: Cyclin D1 and p57 expression in advanced ovarian epithelial carcinoma: A GOG study. [Abstract] J Clin Oncol 29 (Suppl 15): A-5086, 2011.

Darcy KM, Brady WE, Blancato JK, et al.: Prognostic relevance of c-MYC gene amplification and polysomy for chromosome 8 in suboptimally-resected, advanced stage epithelial ovarian cancers: a Gynecologic Oncology Group study. Gynecol Oncol 114 (3): 472-9, 2009.[PUBMED Abstract]

Farley J, Fuchiuji S, Darcy KM, et al.: Associations between ERBB2 amplification and progression-free survival and overall survival in advanced stage, suboptimally-resected epithelial ovarian cancers: a Gynecologic Oncology Group Study. Gynecol Oncol 113 (3): 341-7, 2009.[PUBMED Abstract]

Farley J, Smith LM, Darcy KM, et al.: Cyclin E expression is a significant predictor of survival in advanced, suboptimally debulked ovarian epithelial cancers: a Gynecologic Oncology Group study. Cancer Res 63 (6): 1235-41, 2003.[PUBMED Abstract]

Farley JH, Smith LM, Darcy KM, et al.: Cyclin E expression is a significant predictor of decreased survival in advanced ovarian epithelial cancers: a Gynecologic Oncology Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-859, 2001.

McGuire WP, Hoskins WJ, Brady MF, et al.: Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med 334 (1): 1-6, 1996.[PUBMED Abstract]

McGuire WP, Hoskins WJ, Brady MF, et al.: Taxol and cisplatin (TP) improves outcome in advanced ovarian cancer (AOC) as compared to cytoxan and cisplatin (CP). [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-771, 275, 1995.

Farley J, Smith LM, Darcy KM, et al.: Nuclear P27 expression in benign, borderline (LMP) and invasive tumors of the ovary and its association with prognosis: a gynecologic oncology group study. Gynecol Oncol 121 (2): 395-401, 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]

Darcy KM, Brady WE, McBroom JW, et al.: Associations between p53 overexpression and multiple measures of clinical outcome in high-risk, early stage or suboptimally-resected, advanced stage epithelial ovarian cancers A Gynecologic Oncology Group study. Gynecol Oncol 111 (3): 487-95, 2008.[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]

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]

Almadrones L, McGuire DB, Walczak JR, et al.: Psychometric evaluation of two scales assessing functional status and peripheral neuropathy associated with chemotherapy for ovarian cancer: a gynecologic oncology group study. Oncol Nurs Forum 31 (3): 615-23, 2004.[PUBMED Abstract]

Piccart MJ, Bertelsen K, James K, et al.: Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results. J Natl Cancer Inst 92 (9): 699-708, 2000.[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]

Meerpohl HG, du Bois A, Luck HJ, et al.: Paclitaxel combined with carboplatin in the first-line treatment of advanced ovarian cancer: a phase I trial. Semin Oncol 24 (1 Suppl 2): S2-17-S2-22, 1997.[PUBMED Abstract]

Arbuck S, Strauss H, Christian M, et al.: A reassessment of cardiac toxicity associated with taxol. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-350, 138, 1993.

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]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

William McGuire, MD, Protocol chair		Ph: 443-777-7826; 877-715-4673

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