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Nitrocamptothecin in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer
This study has been completed.
Study NCT00006267   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
 
 
 
 
Complete list of historical versions of study NCT00006267 on ClinicalTrials.gov Archive Site
 
 
 
Nitrocamptothecin in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer
A Phase II Evaluation Of 9-Nitro-Camptothecin In The Third-Line Treatment Of Recurrent Ovarian Or Primary Peritoneal 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 recurrent or metastatic ovarian epithelial or primary peritoneal cancer.

OBJECTIVES:

  • Determine the antitumor activity of nitrocamptothecin in patients with recurrent or metastatic ovarian epithelial or primary peritoneal cancer.
  • Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: Patients receive oral nitrocamptothecin on days 1-5. Treatment continues every 7 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 weeks, then every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 22 months.

Phase II
Interventional
Treatment
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
Drug: rubitecan
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer
  • Measurable disease

    • Ascites and pleural effusions are not considered measurable
    • Sonography allowed if bidimensionally measurable
  • Must not be eligible for higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Granulocyte count at least 1,500/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and alkaline phosphatase no greater than 3 times ULN

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

  • No other prior or concurrent invasive malignancy in the past 5 years except nonmelanoma skin cancer
  • No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least but no more than 2 prior chemotherapy regimens containing carboplatin, cisplatin, or another organoplatinum compound combined with paclitaxel
  • Second line therapy may include any agents except topoisomerase I inhibitors (i.e., topotecan)
  • No prior nitrocamptothecin or topoisomerase I inhibitors
  • At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 3 weeks since prior radiotherapy and recovered

Surgery:

  • At least 3 weeks since prior surgery and recovered

Other:

  • No prior cancer therapy that contraindicates this study
Female
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00006267
 
CDR0000068210, GOG-0186B
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Edward C. Grendys, MD Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
May 2004

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