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

Alternate Title

Chemotherapy in Treating Women With Advanced Ovarian Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	any age		MRC-ICON3 EU-95035

Objectives

I.  Compare the overall and progression-free survival and complete response 
rate in women with advanced ovarian cancer treated with paclitaxel/carboplatin 
vs. a control arm of carboplatin or CAP (cyclophosphamide, doxorubicin, 
cisplatin) as first-line therapy.

II.  Assess patient quality of life in relation to treatment-related toxicity 
and anxiety and depression.

III.  Compare treatment costs during the first 6 months of study.

Entry Criteria

Disease Characteristics:

Histologically and clinically diagnosed invasive epithelial ovarian carcinoma

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy

Surgery:
  Recommended minimum surgical procedures (if possible):
     Total hysterectomy and bilateral salpingo-oophorectomy (as appropriate)
     Omentectomy

Patient Characteristics:

Age:
  Not specified

Performance status:
  Not specified

Hematopoietic:
  Not specified

Hepatic:
  Bilirubin less than 2 x normal

Renal:
  Not specified

Other:
  No sepsis
  No contraindication to platinum-based chemotherapy

Expected Enrollment

A maximum of 2,000 patients will be entered.

Outline

Randomized study.  Patients are randomized 1:2 to Arms I and II.  The choice 
of control treatment on Arm II must be made prior to randomization and is at 
the discretion of the investigator and the patient.

The following acronyms are used:
    CAP        CTX/DOX/CDDP
    CBDCA      Carboplatin, NSC-241240
    CDDP       Cisplatin, NSC-119875
    CTX        Cyclophosphamide, NSC-26271
    DOX        Doxorubicin, NSC-123127
    TAX        Paclitaxel (Bristol-Myers Squibb), NSC-125973

Arm I:  2-Drug Combination Chemotherapy.  TAX/CBDCA.

Arm II:  Single-Agent or 3-Drug Combination Chemotherapy.  CBDCA or CAP.

Colombo N: Randomised trial of paclitaxel (PTX) and carboplatin (CBDCA) versus a control arm of carboplatin or CAP (cyclophosphamide, doxorubicin & cisplatin): The Third International Collaborative Ovarian Neoplasm study (ICON3). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1500, 2000.

Harper P: A Randomised Comparison of Paclitaxel (T) and Carboplatin (J) Versus a Control Arm of Single Agent Carboplatin (J) or CAP (cyclophosphamide, Doxorubicin and Cisplatin): 2075 Patients Randomised Into the 3rd International Collaborative Ovarian Neoplasm Study (ICON3) (Meeting abstract). [Abstract] Proceedings of the American Society of Clinical Oncology 18: A-1375, 1999.

Poole CJ: A randomised comparison of paclitaxel (T) and carboplatin (J) versus a control arm of single agent carboplatin (J) or cyclophosphamide, doxorubicin and cisplatin (CAP): 2074 patients randomised into the 3rd International Collaborative Ovarian Neoplasm study (ICON3). [Abstract] Br J Cancer 80 (suppl 2): A-2.11, 14, 1999.

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]

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]

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Peter Harper, MD, Protocol chair		Ph: 44-207-188-4255 Email: peter.harper@kcl.ac.uk