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CompletedNCT00006230Updated Sep 24, 2012

Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer

A Phase 2 interventional study of rubitecan in Ovarian Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 13 sites in 7 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-24.

Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
51
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Ovarian Cancer

Keywords

  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 726 are open to participants now.

This study's enrollment of 51 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Enrollment
51 participants (actual)

Interventions

  • Drugrubitecan
06

Study locations

13 sites
  • Institut Jules Bordet
    Brussels, B-1000, Belgium
  • Centre Jean Perrin
    Clermont-Ferrand, 63011, France
  • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
    Dijon, 21079, France
  • CHU de la Timone
    Marseille, 13385, France
  • CRLCC Nantes - Atlantique
    Nantes-Saint Herblain, 44805, France
  • Centre Eugene Marquis
    Rennes, 35042, France
  • Rabin Medical Center - Beilinson Campus
    Petah-Tikva, 49100, Israel
  • Azienda Ospedaliera di Padova
    Padova (Padua), 35128, Italy
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
  • Ospedale San Giovanni
    Bellinzona, 6500, Switzerland
  • Clinique De Genolier
    Genolier, Ch-1272, Switzerland
  • Newcastle General Hospital
    Newcastle Upon Tyne, England NE4 6BE, United Kingdom
  • Western General Hospital
    Edinburgh, Scotland EH4 2XU, United Kingdom
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00006230
Lead sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
May 2000
Primary completion
Apr 2003
Last update
Sep 24, 2012

Study contacts

Pierre Fumoleau, MD, PhD
study chair · Centre Georges Francois Leclerc
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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