Phase III Randomized Study of Paclitaxel With Either Carboplatin or Cisplatin Versus Conventional Platinum-Based Chemotherapy in Patients With Relapsed Ovarian Epithelial or Peritoneal Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

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Alternate Title

Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed Ovarian Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedNot specifiedOtherMRC-ICON4
EU-96051, ISRCTN47434271, NCT00002894

Objectives

  1. Compare survival of patients with relapsed ovarian epithelial or peritoneal cancer treated with paclitaxel and either carboplatin or cisplatin vs conventional platinum-based chemotherapy.
  2. Compare the quality of life and health economics of these regimens in these patients.

Entry Criteria

Disease Characteristics:

  • Ovarian epithelial cancer or serous peritoneal carcinoma that has relapsed after prior chemotherapy
    • Progression-free interval (from end of last treatment) of at least 6 months
  • Measurable disease not required

Prior/Concurrent Therapy:

    Biologic therapy

  • Not specified

    Chemotherapy

  • See Disease Characteristics

    Endocrine therapy

  • Not specified

    Radiotherapy

  • Not specified

    Surgery

  • Not specified

Patient Characteristics:

    Age:

  • Not specified

    Performance status:

  • Not specified

    Life expectancy:

  • Not specified

    Hematopoietic:

  • Not specified

    Hepatic:

  • Bilirubin less than 2 times normal

    Renal:

  • Not specified

    Other:

  • No sepsis
  • No contraindication to chemotherapy

Expected Enrollment

800

A maximum of 800 patients will be accrued for this study.

Outline

This is a randomized study. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive platinum-based chemotherapy (that is familiar to the oncologist and used routinely by the center) comprising either cisplatin or carboplatin alone or cisplatin in combination with other drugs.
  • Arm II: Patients receive paclitaxel IV over 3 hours followed by either carboplatin or cisplatin.

Treatment for both arms continues every 3 weeks for up to 6 courses in the absence of unacceptable toxicity.

Quality of life is assessed.

Patients are followed at 6 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Published Results

Ledermann JA: Randomised trial of paclitaxel in combination with platinum chemotherapy versus platinum-based chemotherapy in the treatment of relapsed ovarian cancer (ICON4/OVAR2.2). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1794, 446, 2003.

Parmar MK, Ledermann JA, Colombo N, et al.: Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet 361 (9375): 2099-106, 2003.[PUBMED Abstract]

Related Publications

Kushner DM, Connor JP, Sanchez F, et al.: Weekly docetaxel and carboplatin for recurrent ovarian and peritoneal cancer: a phase II trial. Gynecol Oncol 105 (2): 358-64, 2007.[PUBMED Abstract]

Pfisterer J, Ledermann JA: Management of platinum-sensitive recurrent ovarian cancer. Semin Oncol 33 (2 Suppl 6): S12-6, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Jonathan Ledermann, MD, Protocol chair
Ph: 44-20-7380-9093
Email: jonathan.ledermann@uclh.nhs.uk

Registry Information

Official TitleA RANDOMISED TRIAL OF PACLITAXEL (TAXOL) IN COMBINATION WITH PLATINUM CHEMOTHERAPY VS. CONVENTIONAL PLATINUM-BASED CHEMOTHERAPY IN THE TREATMENT OF WOMEN WITH RELAPSED OVARIAN CANCER
Trial Start Date1996-03-01
Registered in ClinicalTrials.govNCT00002894
Date Submitted to PDQ1996-03-01
Information Last Verified2001-02-16

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.