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Clinical Trials (PDQ®)

  • Last Modified: 1/9/2008

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Clinical Trials (PDQ®)

Phase III Randomized Study of TAX/CDDP vs CTX/CDDP in Patients with Advanced Epithelial Ovarian Cancer

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedno age specifiedEORTC-55931
CAN-NCIC-OV10, SCOTTISH-GYN-G42, SGCSG-NOCOVA-9410, OV10

Objectives

I.  Investigate whether progression-free survival is improved with first-line 
chemotherapy with paclitaxel/cisplatin compared to cyclophosphamide/cisplatin 
in patients with advanced ovarian cancer.

II.  Compare the clinical complete response rates, overall survival, 
qualitative and quantitative toxicities, quality of life, and cost 
effectiveness associated with the two regimens.

III.  Prospectively confirm that a CA-125 serum half-life less than 20 days or 
a 7-fold or greater fall in CA-125 in response to chemotherapy are predictions 
of improved survival.

Entry Criteria

Disease Characteristics:


Histologically confirmed epithelial ovarian carcinoma (by 1973
WHO histologic classification)

FIGO Stage IIB/IIC/III/IV disease with or without successful
debulking at staging laparotomy eligible

No borderline ovarian tumors or abdominal adenocarcinoma of
unknown origin

No complete bowel obstruction

No brain metastases


Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy

Surgery:
  No more than 8 weeks since initial surgery


Patient Characteristics:


Age:
  Not specified

Performance status:
  WHO 0-3

Hematopoietic:
  ANC at least 1,500
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.4 mg/dl (25 micromoles/liter)

Renal:
  Creatinine no greater than 1.5 mg/dl (134 micromoles/liter)
     in patients weighing 45 kg or greater and no greater than
     1.3 mg/dl (115 micromoles/liter) in patients weighing less
     than 45 kg OR
  Creatinine clearance at least 60 ml/min

Cardiovascular:
  No MI within 6 months (unless only evidence is on
     pretreatment EKG)
  No history of CHF even if medically controlled
  No history of medically significant atrial or ventricular
     arrhythmia even if medically controlled

Other:
  No active infection
  No prior allergic reaction to drugs containing Cremophor
     (e.g., cyclosporine or vitamin K)
  No other serious underlying medical condition that would
     preclude protocol therapy
  No second malignancy except adequately treated:
     Basal cell skin carcinoma
     In situ carcinoma of the cervix


Expected Enrollment

Up to 600 patients will be accrued over 18-24 months.

Outline

Randomized study.

Arm I:  2-Drug Combination Chemotherapy.  CP:  Cisplatin, CDDP, NSC-119875; 
Cyclophosphamide, CTX, NSC-26271.

Arm II:  2-Drug Combination Chemotherapy.  CDDP; Paclitaxel (Bristol-Myers), 
Taxol, TAX, NSC-125973.

Published Results

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]

Piccart MJ, Bertelsen K, Stuart G, et al.: Long-term follow-up confirms a survival advantage of the paclitaxel-cisplatin regimen over the cyclophosphamide-cisplatin combination in advanced ovarian cancer. Int J Gynecol Cancer 13 (Suppl 2): 144-8, 2003 Nov-Dec.[PUBMED Abstract]

Carey MS, Bacon M, Tu D, et al.: The prognostic effects of performance status and quality of life scores on progression-free survival and overall survival in advanced ovarian cancer. Gynecol Oncol 108 (1): 100-5, 2008.[PUBMED Abstract]

Rustin GJ, Timmers P, Nelstrop A, et al.: Comparison of CA-125 and standard definitions of progression of ovarian cancer in the intergroup trial of cisplatin and paclitaxel versus cisplatin and cyclophosphamide. J Clin Oncol 24 (1): 45-51, 2006.[PUBMED Abstract]

Green JA, Duffaud F, Coens C, et al.: Prognostic value of clinical and molecular markers in advanced ovarian cancer (AOC): importance of residual (Rs) disease. Translational study using tumor specimens from EORTC 55931/NCIC OV10 Phase III Randomized Clinical Trial (RCT). [Abstract] J Clin Oncol 23 (Suppl 16): A-5005, 456s, 2005.

Bezjak A, Tu D, Bacon M, et al.: Quality of life in ovarian cancer patients: comparison of paclitaxel plus cisplatin, with cyclophosphamide plus cisplatin in a randomized study. J Clin Oncol 22 (22): 4595-603, 2004.[PUBMED Abstract]

Butler L, Bacon M, Carey M, et al.: Determining the relationship between toxicity and quality of life in an ovarian cancer chemotherapy clinical trial. J Clin Oncol 22 (12): 2461-8, 2004.[PUBMED Abstract]

Related Publications

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

European Organization for Research and Treatment of Cancer

Sergio Pecorelli, MD, Protocol chair
Ph: 39-030-399-5341
Email: pecorell@med.unibs.it

NCIC-Clinical Trials Group

Gavin Stuart, MD, Protocol chair
Ph: 403-944-1721
Email: gavinst@cancerboard.ab.ca

Scottish Gynaecological Cancer Study Group

Stanley Kaye, MD, FRCP, Protocol chair
Ph: 44-20-8661-3539
Email: stan.kaye@icr.ac.uk

Lower Bucks Hospital

Kamma Bertelsen, MD, PhD, Protocol chair
Ph: 45-6541-2990

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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