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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002894
• Other study ID #: CDR0000065217
• Secondary ID: MRC-ICON4EU-9605
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 18, 2013
• Start date: March 1996
• Est. completion date: June 2003

Study information

• Verified date: February 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of platinum-based chemotherapy with or without paclitaxel in treating patients with relapsed ovarian epithelial cancer.

Description:

OBJECTIVES:

• Compare survival of patients with relapsed ovarian epithelial or peritoneal cancer treated with paclitaxel and either carboplatin or cisplatin vs conventional platinum-based chemotherapy.

• Compare the quality of life and health economics of these regimens in these patients.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• carboplatin

• cisplatin

• paclitaxel

Locations

Country	Name	City	State
United Kingdom	Middlesex Hospital- Meyerstein Institute	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Kushner DM, Connor JP, Sanchez F, Volk M, Schink JC, Bailey HH, Harris LS, Stewart SL, Fine J, Hartenbach EM; Wisconsin Oncology Network. Weekly docetaxel and carboplatin for recurrent ovarian and peritoneal cancer: a phase II trial. Gynecol Oncol. 2007 May;105(2):358-64. Epub 2007 Jan 29. — View Citation

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:

Parmar MK, Ledermann JA, Colombo N, du Bois A, Delaloye JF, Kristensen GB, Wheeler S, Swart AM, Qian W, Torri V, Floriani I, Jayson G, Lamont A, Tropé C; ICON and AGO Collaborators. Paclitaxel plus platinum-based chemotherapy versus conventional platinum- — View Citation

Pfisterer J, Ledermann JA. Management of platinum-sensitive recurrent ovarian cancer. Semin Oncol. 2006 Apr;33(2 Suppl 6):S12-6. Review. — View Citation