Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
NCT ID: NCT00006230
Last Updated: 2012-09-24
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
PHASE2
51 participants
INTERVENTIONAL
2000-05-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced ovarian cancer.
Detailed Description
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* Determine the objective response rate and duration of response in patients with advanced ovarian cancer treated with nitrocamptothecin.
* Determine the probability of objective response as expressed by the response rate in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease status (sensitive vs refractory).
Patients receive oral nitrocamptothecin daily for 5 consecutive days each week for 3 weeks. Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD) receive up to 4 additional courses past SD. Patients who achieve partial response (PR) or complete response (CR) receive a minimum of 2 additional courses past PR or CR.
Patients are followed every 6 weeks until disease progression or the initiation of another antitumor therapy.
PROJECTED ACCRUAL: A total of 28-50 patients (14-25 per stratum) 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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rubitecan
Eligibility Criteria
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Inclusion Criteria
* Histologically proven metastatic or unresectable locally advanced progressive ovarian cancer that has failed first line platinum and taxane based regimen
* Refractory disease defined by a relapse within 1 year after completion of first line therapy
* Sensitive disease defined by a relapse greater than 1 year after completion of first line therapy
* Minimum of 1 target lesion that can be accurately measured in at least 1 dimension
* At least 20 mm by conventional techniques OR
* At least 10 mm by spiral CT scan
* No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase, SGOT, and SGPT no greater than 2.5 times ULN (no greater than 5 times ULN if hepatic metastases present)
Renal:
* Creatinine no greater than 1.7 mg/dL
Cardiovascular:
* No ischemic heart disease within the past 6 months
* Normal 12 lead electrocardiogram
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No unstable systemic disease or active uncontrolled infections
* No other prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer or cone biopsied carcinoma of the cervix
* No psychological, familial, sociological, or geographical condition that would preclude compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent filgrastim (G-CSF) with nitrocamptothecin
Chemotherapy:
* See Disease Characteristics
* Greater than 4 weeks since prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Greater than 4 weeks since prior radiotherapy
Surgery:
* Greater than 2 weeks since prior major surgery
Other:
* No other concurrent anticancer agents
* No other concurrent investigational therapy
18 Years
FEMALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Pierre Fumoleau, MD, PhD
Role: STUDY_CHAIR
Centre Georges Francois Leclerc
Locations
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Institut Jules Bordet
Brussels, , Belgium
Centre Jean Perrin
Clermont-Ferrand, , France
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, , France
CHU de la Timone
Marseille, , France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , France
Centre Eugene Marquis
Rennes, , France
Rabin Medical Center - Beilinson Campus
Petah Tikva, , Israel
Azienda Ospedaliera di Padova
Padova (Padua), , Italy
Hospital Universitario 12 de Octubre
Madrid, , Spain
Ospedale San Giovanni
Bellinzona, , Switzerland
Clinique De Genolier
Genolier, , Switzerland
Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Countries
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Other Identifiers
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EORTC-16996O
Identifier Type: -
Identifier Source: secondary_id
EORTC-16996O
Identifier Type: -
Identifier Source: org_study_id