- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003733
Sequential Chemotherapy in Treating Patients With Residual Disease Following Surgery for Stage IIB, Stage III, or Stage IV Ovarian Cancer
A Phase II Study of Sequential Carboplatin, Paclitaxel and Hycamtin in Patients With Previously Untreated Advanced Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Evaluate the efficacy of sequential carboplatin, paclitaxel, and topotecan in terms of disease response, time to progression, survival and progression free survival in patients with stage IIB, stage III, or stage IV ovarian epithelial cancer. II. Assess the toxicity of this regimen in this patient population.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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England
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London, England, United Kingdom, W6 8RF
- Charing Cross Hospital
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Northwood, England, United Kingdom, HA6 2RN
- Mount Vernon Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial carcinoma with greater than 1 cm residual disease at completion of initial surgery Stage IIB, IIIA, IIIB, IIIC, or IV Measurable disease OR CA 125 greater than 120 units/mL obtained post surgery
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
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
Keywords
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
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Carboplatin
- Paclitaxel
- Topotecan
Other Study ID Numbers
- CDR0000066848
- SB-104864/289
- EU-98068
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
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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
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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
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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
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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
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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
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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
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Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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University of WashingtonMinnesota Ovarian Cancer AllianceTerminatedStage 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 IVA Ovarian Cancer AJCC v8 | Stage IVB Ovarian... and other conditionsUnited States
Clinical Trials on carboplatin
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Eisai Inc.CompletedCancerUnited States, Austria, India
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Samyang Biopharmaceuticals CorporationCompleted
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NHS Greater Glasgow and ClydeCompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity CancerUnited Kingdom, Australia, New Zealand
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Duke UniversityCompletedBrain and Central Nervous System TumorsUnited States, Canada
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National Cancer Institute (NCI)CompletedBreast Cancer | Ovarian CancerUnited States
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National Cancer Institute (NCI)Children's Oncology GroupCompletedBrain and Central Nervous System TumorsUnited States, Canada, Puerto Rico, Australia, Netherlands, New Zealand, Switzerland
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All India Institute of Medical Sciences, New DelhiCouncil of Scientific and Industrial Research, IndiaUnknownIntraocular RetinoblastomaIndia
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MEI Pharma, Inc.CompletedPeritoneal Neoplasms | Ovarian Cancer | Fallopian Tube CancerUnited States, Spain, Belgium, United Kingdom, Australia, Italy, Poland
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Medical Research CouncilEuropean Organisation for Research and Treatment of Cancer - EORTCCompletedTesticular Germ Cell TumorUnited Kingdom, Canada, Norway, Netherlands, South Africa, Brazil, Finland
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AkesoRecruitingAdvanced Squamous Non Small Cell Lung CancerChina