Carboplatin Plus Paclitaxel or Docetaxel in Treating Patients With Ovarian Epithelial Cancer
NCT ID: NCT00003998
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
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COMPLETED
PHASE3
1050 participants
INTERVENTIONAL
1998-10-31
2004-12-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus paclitaxel with that of carboplatin plus docetaxel in treating patients who have ovarian epithelial cancer.
Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are stratified by residual disease (none or microscopic vs macroscopic no greater than 2 cm vs or macroscopic greater than 2 cm), study center, FIGO stage (IC-IV), performance status (0 vs 1 vs 2), tumor grade (well-defined vs moderately defined vs poorly defined/undifferentiated vs unknown), interval debulking intention (yes vs no vs randomized into OV06 trial), elevated CA125 prior to treatment (yes vs no), and primary peritoneal cancer (yes vs no). Patients may undergo interval debulking surgery within 4 weeks of the third course of chemotherapy, or following 6 courses of treatment. Patients undergoing interval debulking after 3 courses should resume chemotherapy within 3 weeks of surgery. Patients are randomized into one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours, immediately followed by carboplatin IV over 1 hour. Arm II: Patients receive docetaxel IV over 1 hour, immediately followed by carboplatin IV over 1 hour. Courses are repeated every 21 days. Treatment continues for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with partial or complete response may receive 3 additional courses of carboplatin alone thereafter. Quality of life is assessed at baseline, prior to each treatment course, and then every 4 months for 2 years or until disease progression. Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 1050 patients will be accrued for this study within 2.25 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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carboplatin
docetaxel
paclitaxel
surgical procedure
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) OR ALT or AST no greater than 1.5 times ULN OR Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No hypertension No ischemic heart disease No myocardial infarction within the past 6 months No congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled infection No other concurrent severe and/or uncontrolled comorbid medical condition No prior malignancy within the past 5 years, except: Curatively treated carcinoma in situ of the cervix Basal cell skin cancer No other concurrent malignancy (e.g., endometrial cancer) No prior serious allergic reaction (e.g., anaphylactic shock) No symptomatic grade 2 or greater peripheral neuropathy
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Prior surgery allowed
18 Years
FEMALE
No
Sponsors
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University of Glasgow
OTHER
Principal Investigators
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Paul A. Vasey, MD
Role: STUDY_CHAIR
University of Glasgow
Locations
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C.R.C. Beatson Laboratories
Glasgow, Scotland, United Kingdom
Countries
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References
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Marsh S, Paul J, King CR, Gifford G, McLeod HL, Brown R. Pharmacogenetic assessment of toxicity and outcome after platinum plus taxane chemotherapy in ovarian cancer: the Scottish Randomised Trial in Ovarian Cancer. J Clin Oncol. 2007 Oct 10;25(29):4528-35. doi: 10.1200/JCO.2006.10.4752.
Crawford SC, Vasey PA, Paul J, Hay A, Davis JA, Kaye SB. Does aggressive surgery only benefit patients with less advanced ovarian cancer? Results from an international comparison within the SCOTROC-1 Trial. J Clin Oncol. 2005 Dec 1;23(34):8802-11. doi: 10.1200/JCO.2005.02.1287.
Vasey PA, Jayson GC, Gordon A, Gabra H, Coleman R, Atkinson R, Parkin D, Paul J, Hay A, Kaye SB; Scottish Gynaecological Cancer Trials Group. Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-line chemotherapy for ovarian carcinoma. J Natl Cancer Inst. 2004 Nov 17;96(22):1682-91. doi: 10.1093/jnci/djh323.
Other Identifiers
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CRC-BOC-SCOTROC
Identifier Type: -
Identifier Source: secondary_id
EU-99010
Identifier Type: -
Identifier Source: secondary_id
CDR0000067208
Identifier Type: -
Identifier Source: org_study_id