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Nitrocamptothecin in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006267
Recruitment Status : Withdrawn (Never activated.)
First Posted : January 27, 2003
Last Update Posted : July 9, 2013
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

Brief 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 recurrent or metastatic ovarian epithelial or primary peritoneal cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: rubitecan Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: A Phase II Evaluation Of 9-Nitro-Camptothecin In The Third-Line Treatment Of Recurrent Ovarian Or Primary Peritoneal Cancer
Primary Completion Date : May 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified


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


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


  • Creatinine no greater than 2.0 mg/dL


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


Biologic therapy:

  • Not specified


  • 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


  • At least 3 weeks since prior radiotherapy and recovered


  • At least 3 weeks since prior surgery and recovered


  • No prior cancer therapy that contraindicates this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006267

Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Edward C. Grendys, MD Robert H. Lurie Cancer Center Identifier: NCT00006267     History of Changes
Other Study ID Numbers: CDR0000068210
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: May 2004

Keywords provided by Gynecologic Oncology Group:
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Peritoneal Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action