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Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rubitecan
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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

Sites / Locations

  • Institut Jules Bordet
  • Centre Jean Perrin
  • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
  • CHU de la Timone
  • CRLCC Nantes - Atlantique
  • Centre Eugene Marquis
  • Rabin Medical Center - Beilinson Campus
  • Azienda Ospedaliera di Padova
  • Hospital Universitario 12 de Octubre
  • Ospedale San Giovanni
  • Clinique De Genolier
  • Newcastle General Hospital
  • Western General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2000
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00006230
Brief Title
Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
Official Title
Open Label Phase II Study on RFS 2000 (9-Nitro-camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced ovarian cancer.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rubitecan

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Fumoleau, MD, PhD
Organizational Affiliation
Centre Georges Francois Leclerc
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
B-1000
Country
Belgium
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CRLCC Nantes - Atlantique
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Rabin Medical Center - Beilinson Campus
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Azienda Ospedaliera di Padova
City
Padova (Padua)
ZIP/Postal Code
35128
Country
Italy
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Ospedale San Giovanni
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Clinique De Genolier
City
Genolier
ZIP/Postal Code
Ch-1272
Country
Switzerland
Facility Name
Newcastle General Hospital
City
Newcastle Upon Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom

12. IPD Sharing Statement

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Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer

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