- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002894
Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed Ovarian Cancer
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
England
-
London, England, United Kingdom, WIT 3AA
- Middlesex Hospital- Meyerstein Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jonathan A. Ledermann, MD, University College London Hospitals
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- CDR0000065217
- MRC-ICON4
- EU-96051
- ISRCTN47434271
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
-
Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
-
Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)TerminatedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Nausea and Vomiting | Ovarian Brenner Tumor | Ovarian Mucinous Cystadenocarcinoma | Undifferentiated Ovarian Carcinoma | Stage IIA Fallopian Tube Cancer | Stage... and other conditionsUnited States
Clinical Trials on carboplatin
-
Eisai Inc.CompletedCancerUnited States, Austria, India
-
Samyang Biopharmaceuticals CorporationCompleted
-
NHS Greater Glasgow and ClydeCompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity CancerUnited Kingdom, Australia, New Zealand
-
Duke UniversityCompletedBrain and Central Nervous System TumorsUnited States, Canada
-
National Cancer Institute (NCI)CompletedBreast Cancer | Ovarian CancerUnited States
-
National Cancer Institute (NCI)Children's Oncology GroupCompletedBrain and Central Nervous System TumorsUnited States, Canada, Puerto Rico, Australia, Netherlands, New Zealand, Switzerland
-
All India Institute of Medical Sciences, New DelhiCouncil of Scientific and Industrial Research, IndiaUnknownIntraocular RetinoblastomaIndia
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Eli Lilly and CompanyCompletedLung NeoplasmsUnited States
-
MEI Pharma, Inc.CompletedPeritoneal Neoplasms | Ovarian Cancer | Fallopian Tube CancerUnited States, Spain, Belgium, United Kingdom, Australia, Italy, Poland