Sequential Chemotherapy in Treating Patients With Residual Disease Following Surgery for Stage IIB, Stage III, or Stage IV Ovarian Cancer
NCT ID: NCT00003733
Last Updated: 2013-09-20
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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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
1997-12-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of sequential chemotherapy in treating patients with residual disease following surgery for stage IIB, stage III, or stage IV ovarian cancer.
Detailed Description
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OUTLINE: Patients receive carboplatin IV over 30 to 60 minutes on days 1 and 22. Patients then receive paclitaxel IV over 3 hours on days 43 and 64, then topotecan IV over 30 minutes daily for 5 days beginning on days 85, 106, 127, and 148. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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carboplatin
paclitaxel
topotecan hydrochloride
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: See General Eligibility Criteria
PRIOR CONCURRENT THERAPY: Biological therapy: No prior or concurrent immunotherapy Chemotherapy: No prior or concurrent chemotherapy Endocrine: No prior or concurrent hormonal therapy Radiotherapy: No prior radiotherapy No concurrent radiotherapy except to limited fields (e.g., for palliation of bone pain) Surgery: Diagnostic surgery performed less than 12 weeks prior to study No concurrent interval debulking Other: At least 30 days or five half-lives since any prior investigational therapy No other concurrent investigational therapy --Patients Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 9.0 g/dL WBC at least 4,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2.5 times ULN (no greater than 5 times ULN if liver and/or bone metastases present) Renal: Creatine less than 2 times ULN Creatinine clearance at least 50 mL/min Other: No prior malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix No uncontrolled infection No other concurrent medical conditions that would prevent full compliance or expose patient to extreme risk or decreased life expectancy No concurrent medical condition for which treament with platinum compounds is contraindicated No history of allergy to compounds related to the drugs used in this study No prior motor or sensory neurotoxicity grade 2 or worse Not pregnant or nursing Fertile patients must use effective contraception
18 Years
FEMALE
No
Sponsors
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SmithKline Beecham
INDUSTRY
Principal Investigators
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Gordon J.S. Rustin, MD
Role: STUDY_CHAIR
Mount Vernon Cancer Centre at Mount Vernon Hospital
Locations
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Charing Cross Hospital
London, England, United Kingdom
Mount Vernon Hospital
Northwood, England, United Kingdom
Countries
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References
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Guppy AE, Nelstrop AE, Foster T, Agarwal R, Seckl MJ, Rustin GJ. A phase II study of sequential carboplatin, paclitaxel and topotecan in patients with previously untreated advanced ovarian cancer. Br J Cancer. 2004 Feb 23;90(4):810-4. doi: 10.1038/sj.bjc.6601618.
Other Identifiers
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SB-104864/289
Identifier Type: -
Identifier Source: secondary_id
EU-98068
Identifier Type: -
Identifier Source: secondary_id
CDR0000066848
Identifier Type: -
Identifier Source: org_study_id