Clincosm LogoSign in Get a demo

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

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00006267
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment

Study Details

Study Description

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
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
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
Actual Primary Completion Date :
May 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Edward C. Grendys, MD, Robert H. Lurie Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00006267
    Other Study ID Numbers:
    • CDR0000068210
    • GOG-0186B
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jul 9, 2013
    Last Verified:
    May 1, 2004
    Keywords provided by , ,
    stage IV ovarian epithelial cancer
    recurrent ovarian epithelial cancer
    primary peritoneal cavity cancer
    Additional relevant MeSH terms:
    Rubitecan

    Study Results

    No Results Posted as of Jul 9, 2013