Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

Oxaliplatin and Topotecan in Advance Ovarian Cancer

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Recurrent Ovarian Epithelial Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

This phase II trial is studying how well giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drug...

Detailed Description

PRIMARY OBJECTIVES: I. Estimate the overall clinical response rate (complete and partial responses) in patients with previously treated ovarian epithelial, primary peritoneal, or fallopian tube cance...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • Meets 1 of the following criteria for response to prior platinum-based therapy:
  • Platinum-resistant disease, defined as a disease-free interval of \< 6 months after prior platinum-based therapy OR progressive disease on a platinum-containing regimen
  • Platinum-sensitive disease, defined as a disease-free interval of \> 6 months after prior platinum-based therapy
  • Measurable or evaluable disease: Measurable disease is characterized as lesions reproducibly measurable in 1 dimension; evaluable disease is defined as known disease with CA125 levels \> 50 U/mL on 2 occasions \>= 1 week apart
  • Previously treated with a taxane and platinum-based regimen, only 1 prior platinum-based regimen, including IV or intraperitoneal consolidation, one additional non-platinum and non-topotecan chemotherapy regimen allowed
  • Life expectancy \>= 4 months
  • Total bilirubin =\< 1.5 times upper limit of normal (ULN)
  • AST =\< 2.5 times ULN (5 times ULN if liver metastases are present)
  • Creatinine =\< 1.5 times ULN AND creatinine clearance \> 40 mg/dL
  • Exclusion criteria:
  • No presence of any other active cancer
  • No uncontrolled intercurrent illness, including the following:
  • Infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • No history of severe allergy to platinum compounds
  • (Mild reaction (skin only) allowed provided a negative skin test is obtained)
  • No history of allergic reaction to appropriate antiemetics (e.g., 5HT3 antagonists)
  • Recovered from prior chemotherapy
  • At least 2 weeks since prior radiotherapy and recovered
  • At least 4 weeks since prior investigational drugs
  • No prior radiotherapy to the whole pelvic field
  • No unresolved sequelae resulting from any surgical procedures
  • No concurrent colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) during topotecan infusion
  • No concurrent participation in another investigational trial
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy

Exclusion

    Key Trial Info

    Start Date :

    January 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2012

    Estimated Enrollment :

    39 Patients enrolled

    Trial Details

    Trial ID

    NCT00313612

    Start Date

    January 1 2006

    End Date

    December 1 2012

    Last Update

    November 27 2015

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    NYU Cancer Institute

    New York, New York, United States, 10016

    2

    Montefiore Medical Center

    The Bronx, New York, United States, 10467-2490