Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed Ovarian Cancer
NCT ID: NCT00002894
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
800 participants
INTERVENTIONAL
1996-03-31
2003-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
carboplatin
cisplatin
paclitaxel
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical Research Council
OTHER_GOV
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jonathan A. Ledermann, MD
Role: STUDY_CHAIR
University College London Hospitals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1016/j.ygyno.2006.12.018. Epub 2007 Jan 29.
Pfisterer J, Ledermann JA. Management of platinum-sensitive recurrent ovarian cancer. Semin Oncol. 2006 Apr;33(2 Suppl 6):S12-6. doi: 10.1053/j.seminoncol.2006.03.012.
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, du Bois A, Delaloye JF, Kristensen GB, Wheeler S, Swart AM, Qian W, Torri V, Floriani I, Jayson G, Lamont A, Trope C; ICON and AGO Collaborators. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet. 2003 Jun 21;361(9375):2099-106. doi: 10.1016/s0140-6736(03)13718-x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MRC-ICON4
Identifier Type: -
Identifier Source: secondary_id
EU-96051
Identifier Type: -
Identifier Source: secondary_id
ISRCTN47434271
Identifier Type: -
Identifier Source: secondary_id
CDR0000065217
Identifier Type: -
Identifier Source: org_study_id