Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Pierre Fumoleau, MD, PhD, Centre Georges Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-16996O

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.

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