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Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
This study is ongoing, but not recruiting participants.
Study NCT00006230   Information provided by National Cancer Institute (NCI)
First Received: September 11, 2000   Last Updated: July 23, 2008   History of Changes

September 11, 2000
July 23, 2008
May 2000
 
 
 
Complete list of historical versions of study NCT00006230 on ClinicalTrials.gov Archive Site
 
 
 
Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
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.

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.

Phase II
Interventional
Treatment
Ovarian Cancer
Drug: rubitecan
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Israel,   Italy,   Spain,   Switzerland,   United Kingdom
 
NCT00006230
 
CDR0000068154, EORTC-16996O
European Organization for Research and Treatment of Cancer
 
Study Chair: Pierre Fumoleau, MD, PhD Centre de Lutte Contre le Cancer Georges-Francois Leclerc
National Cancer Institute (NCI)
November 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP