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Clinical Trials (PDQ®)

Phase III Randomized Study of Platinum Compound and Paclitaxel in Optimal Stage III Ovarian Epithelial Cancer: Cisplatin and Paclitaxel (24-Hour Continuous Infusion) vs Carboplatin and Paclitaxel (3-Hour Infusion)

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

Alternate Title

Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompletedany ageNCIGOG-0158
GOG-0158

Objectives

I.  Compare the recurrence-free interval and survival in patients with optimal 
stage III (i.e., no greater than 1 cm in diameter) ovarian epithelial cancer 
randomized to cisplatin and paclitaxel (Taxol) administered as a 24-hour 
continuous infusion vs. carboplatin and paclitaxel administered as a 3-hour 
infusion.

II.  Compare the toxic effects and complications of the 2 treatment regimens.

III.  Correlate serial serum CA 125 levels with recurrence-free interval.

IV.  Determine platinum-DNA adduct levels in the peripheral leukocytes of 
patients receiving platinum-based chemotherapy as first line therapy and to 
correlate platinum DNA adduct formation with response to therapy.

Entry Criteria

Disease Characteristics:


Histologically diagnosed ovarian epithelial carcinoma

Optimal stage III disease, i.e.:
  Residual disease no greater than 1 cm in diameter following appropriate
  cytoreductive surgery

  Node dissection not required for stage IIIC disease with residual,
  measurable, palpable disease less than 1 cm

The following histologies are eligible:
  Serous adenocarcinoma          Adenocarcinoma NOS
  Mucinous adenocarcinoma        Endometrioid adenocarcinoma
  Clear cell adenocarcinoma      Undifferentiated carcinoma
  Transitional cell              Mixed epithelial carcinoma
  Malignant Brenner's tumor

No borderline carcinoma

Patients eligible for this protocol are also eligible for protocol GOG-118


Prior/Concurrent Therapy:


No prior radiotherapy or chemotherapy
No more than 6 weeks since surgery


Patient Characteristics:


Age:
  Any age

Performance status:
  GOG 0-2

Hematopoietic:
  WBC at least 3,000/mm3
  Platelet count at least 100,000/mm3

Hepatic:
  Bilirubin no greater than 1.5 mg/dL
  AST no greater than 3 times normal
  Alkaline phosphatase no greater than 3 times normal
  No acute hepatitis

Renal:
  Creatinine no greater than 2 mg/dL

Cardiovascular:
  No unstable angina
  No myocardial infarction within 6 months
  Abnormal cardiac conduction (e.g., bundle branch or heart block) allowed if
     stable for the past 6 months

Other:
  No severe infection, including septicemia
  No severe gastrointestinal bleeding
  No history of second malignancy within 5 years except nonmelanomatous skin   
   cancer


Expected Enrollment

720 patients will be accrued.

Outline

Randomized study.  The following acronyms are used:
  CBDCA    Carboplatin, NSC-241240
  CDDP     Cisplatin, NSC-119875
  TAXOL      Paclitaxel (Bristol-Myers), NSC-125973

Arm I:  2-Drug Combination Chemotherapy.  Taxol/CDDP.  24-hour continuous 
infusion of Taxol.

Arm II:  2-Drug Combination Chemotherapy.  Taxol/CBDCA.  3-hour infusion of 
Taxol.

Published Results

Bodurka DC, Deavers MT, Tian C, et al.: Reclassification of serous ovarian carcinoma by a 2-tier system: a Gynecologic Oncology Group Study. Cancer 118 (12): 3087-94, 2012.[PUBMED Abstract]

Wright JD, Tian C, Mutch DG, et al.: Carboplatin dosing in obese women with ovarian cancer: a Gynecologic Oncology Group study. Gynecol Oncol 109 (3): 353-8, 2008.[PUBMED Abstract]

Darcy KM, Tian C, Reed E: A Gynecologic Oncology Group study of platinum-DNA adducts and excision repair cross-complementation group 1 expression in optimal, stage III epithelial ovarian cancer treated with platinum-taxane chemotherapy. Cancer Res 67 (9): 4474-81, 2007.[PUBMED Abstract]

Hess LM, Barakat R, Tian C, et al.: Weight change during chemotherapy as a potential prognostic factor for stage III epithelial ovarian carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol 107 (2): 260-5, 2007.[PUBMED Abstract]

Wright JD, Tian C, Mutch DG, et al.: Carboplatin dosing in obese women with ovarian cancer: 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-38, 2007.

Hess LM, Tian C, Barakat R, et al.: Change in patient weight during platinum/paclitaxel-based chemotherapy for ovarian cancer: a Gynecologic Oncology Group study. [Abstract] J Clin Oncol 24 (Suppl 18): A-5073, 273s, 2006.

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]

Ozols RF, Bundy BN, Fowler JM, et al.: Randomized phase III study of cisplatin (CIS)/paclitaxel (PAC) versus Carboplatin (CARBO)/PAC in optimal stage III epithelial ovarian cancer (OC): a Gynecologic Oncology Group trial (GOG 158). [Abstract] Society of Gynecologic Oncologists 2003 Annual Meeting on Women's Cancer, January 31 - February 2, 2003, New Orleans, Louisiana. A-285, 2003.

Ozols RF, Bundy BN, Fowler J, et al.: Randomized phase III study of cisplatin (CIS)/paclitaxel (PAC) versus carboplatin (CARBO)/PAC in optimal stage III epithelial ovarian cancer (OC): a Gynecologic Oncology Group trial (GOG 158). [Abstract] Proceedings of the American Society of Clinical Oncology 18: A-1373, 356a, 1999.

Related Publications

Bookman MA, Greer BE, Ozols RF: Optimal therapy of advanced ovarian cancer: carboplatin and paclitaxel vs. cisplatin and paclitaxel (GOG 158) and an update on GOG0 182-ICON5. Int J Gynecol Cancer 13 (6): 735-40, 2003 Nov-Dec.[PUBMED Abstract]

Bristow RE, Santillan A, Salani R, et al.: Intraperitoneal cisplatin and paclitaxel versus intravenous carboplatin and paclitaxel chemotherapy for Stage III ovarian cancer: a cost-effectiveness analysis. Gynecol Oncol 106 (3): 476-81, 2007.[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]

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]

Havrilesky LJ, Secord AA, Darcy KM, et al.: 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 26 (25): 4144-50, 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]

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]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Robert Ozols, MD, PhD, Protocol chair
Ph: 215-728-2673; 888-369-2427
Email: robert.ozols@fccc.edu

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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