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

Alternate Title

Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed Ovarian Cancer

Basic Trial Information

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

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.

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]

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 Title		A 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 Date		1996-03-01
Registered in ClinicalTrials.gov		NCT00002894
Date Submitted to PDQ		1996-03-01
Information Last Verified		2001-02-16

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