NCT00006230

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Geographic Reach
7 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

2.9 years

First QC Date

September 11, 2000

Last Update Submit

September 20, 2012

Conditions

Ovarian Cancer

Keywords

stage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancer

Interventions

rubitecanDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (13)

Institut Jules Bordet

Brussels, B-1000, Belgium

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

Dijon, 21079, France

Location

CHU de la Timone

Marseille, 13385, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Rabin Medical Center - Beilinson Campus

Petah Tikva, 49100, Israel

Location

Azienda Ospedaliera di Padova

Padova (Padua), 35128, Italy

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Ospedale San Giovanni

Bellinzona, 6500, Switzerland

Location

Clinique De Genolier

Genolier, Ch-1272, Switzerland

Location

Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

rubitecan

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Pierre Fumoleau, MD, PhD

    Centre Georges Francois Leclerc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Study Start

May 1, 2000

Primary Completion

April 1, 2003

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

BE(1)IL(1)ES(1)CH(2)IT(1)GB(2)FR(5)