RATIONALE: It is not yet known if treatment for recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer is more effective if it is begun when blood levels of CA 125 become elevated rather than waiting for other indicators of disease recurrence.

PURPOSE: This randomized phase III trial is studying early chemotherapy based on blood levels of CA 125 alone to see how well it works compared to chemotherapy based on conventional clinical indicators in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Condition	Treatment or Intervention	Phase
recurrent ovarian epithelial cancer peritoneal cavity cancer Fallopian Tube Cancer	Procedure: chemotherapy	Phase III

Further Study Details: 

OBJECTIVES:

• Compare the benefit of early chemotherapy based on CA 125 level only vs chemotherapy based on conventional clinical indicators in patients with relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer.
• Compare the overall survival of patients treated with these regimens.
• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients whose CA 125 levels rise to more than two times the upper limit of normal are randomized to one of two treatment arms.

• Arm I: The clinician is informed of the initial rise in CA 125 level. A confirmatory test is performed immediately. Within 4 weeks of the initial CA 125 elevation, patients with a second confirmed elevation receive treatment for recurrent disease according to standard local practice. Patients with a normal CA 125 on the confirmatory test receive no treatment until clinically indicated.
• Arm II: The clinician is blinded to the CA 125 results. Patients undergo normal monitoring. When clinically indicated, patients commence treatment according to standard local practice. Quality of life is assessed at baseline, at each follow-up visit, and, if treatment is instituted, before each chemotherapy course.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 1,400 patients will be accrued for this study.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer
• Achieved complete remission with normal CA 125 after first-line platinum-containing chemotherapy
• Prior participation in the following clinical trials is allowed:
• MRC-ICON2 (carboplatin vs cyclophosphamide, doxorubicin, and cisplatin for advanced disease)
• MRC-ICON3 (paclitaxel with carboplatin in first-line therapy for advanced disease)
• MRC-ICON5 (carboplatin and paclitaxel vs triplet and sequential doublet combinations of chemotherapy)
• No prior participation in MRC-ICON1 (adjuvant chemotherapy for early-stage ovarian cancer)

PATIENT CHARACTERISTICS: Age:

• Not specified

Performance status:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No prior or concurrent malignancy within the past 5 years that is likely to preclude study treatment or comparisons except for nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Austria
      Kaiser Franz Josef Hospital, Vienna,  A-1100,  Austria; Recruiting
Belgium
      Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels,  1090,  Belgium; Recruiting
      Cazk Groeninghe - Campus Maria's Voorzienigheid, Kortrijk,  B-8500,  Belgium; Recruiting
      Institut Jules Bordet, Brussels,  1000,  Belgium; Recruiting
France
      Centre Regional Francois Baclesse, Caen,  14076,  France; Recruiting
Ireland
      Coombe Women's Hospital, Dublin,  8,  Ireland; Recruiting
      St. James's Hospital, Dublin,  8,  Ireland; Recruiting
Italy
      Spedali Civili, Brescia,  25124,  Italy; Recruiting
Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands; Recruiting
      Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam,  3008 AE,  Netherlands; Recruiting
      Isala Klinieken - locatie Sophia, Zwolle,  8000 GK,  Netherlands; Recruiting
      Leiden University Medical Center, Leiden,  2300 RC,  Netherlands; Recruiting
      Leyenburg Ziekenhuis, S. Gravenhage,  2545 CH,  Netherlands; Recruiting
      University Medical Center Nijmegen, Nijmegen,  NL-6500 HB,  Netherlands; Recruiting
      University Medical Center Utrecht, Utrecht,  3508 GA,  Netherlands; Recruiting
Portugal
      Hospitais da Universidade de Coimbra (HUC), Coimbra,  3001-301,  Portugal; Recruiting
South Africa
      Groote Schuur Hospital, Cape Town,  7925,  South Africa; Recruiting
Spain
      Hospital Universitario 12 de Octubre, Madrid,  28041,  Spain; Recruiting
      Hospital Universitario San Carlos, Madrid,  28040,  Spain; Recruiting
      Institut d'Oncologia Corachan, Barcelona,  08017,  Spain; Recruiting
United Kingdom, England
      Mount Vernon Hospital, Northwood,  England,  HA6 2RN,  United Kingdom; Recruiting

Study chairs or principal investigators

Gordon John Sampson Rustin, MD,  Mount Vernon Hospital   
M.E.L. van der Burg, MD, PhD,  University Medical Center Rotterdam at Erasmus Medical Center   

Study ID Numbers:  CDR0000065218; MRC-OV05; EORTC-55955; ISRCTN87786644; NCT00002895
Record last reviewed:  December 2004
Last Updated:  April 4, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002895
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08