Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00006230
First received: September 11, 2000
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: rubitecan
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 51
Study Start Date: May 2000
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006230

Locations
Belgium
Institut Jules Bordet
Brussels, Belgium, B-1000
France
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, France, 21079
CHU de la Timone
Marseille, France, 13385
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Centre Eugene Marquis
Rennes, France, 35042
Israel
Rabin Medical Center - Beilinson Campus
Petah-Tikva, Israel, 49100
Italy
Azienda Ospedaliera di Padova
Padova (Padua), Italy, 35128
Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Switzerland
Ospedale San Giovanni
Bellinzona, Switzerland, 6500
Clinique De Genolier
Genolier, Switzerland, Ch-1272
United Kingdom
Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Pierre Fumoleau, MD, PhD Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00006230     History of Changes
Other Study ID Numbers: EORTC-16996O, EORTC-16996O
Study First Received: September 11, 2000
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014