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EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
This study has been completed.
Study NCT00035100   Information provided by Novartis
First Received: May 2, 2002   Last Updated: September 18, 2009   History of Changes

May 2, 2002
September 18, 2009
 
 
Maximum tolerated dose
Response
Complete list of historical versions of study NCT00035100 on ClinicalTrials.gov Archive Site
  • Time to progression
  • Overall survival
Same as current
 
EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
Drug: epothilone b
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
48
 
 

Inclusion Criteria

The following patients may be eligible for the study:

  • Histologically or cytologically documented evidence of ovarian, primary Fallopian or primary peritoneal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
  • Must have a life expectancy of greater than three (3) months
  • Prior failure to respond following front-line treatment with a taxane and platinum (or a combination therapy) may be eligible.

Exclusion Criteria

The following patients are not eligible for the study:

  • Patients with radiation therapy or chemotherapy within the last four weeks
  • Patients who have had any chemotherapy not containing a taxane and platinum for their disease
  • Patients with borderline ovarian and macropapillary tumors
  • Patients with unresolved bowel obstruction
  • Patients with symptomatic CNS metastases or leptomeningeal involvement
  • Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
  • Patients with severe cardiac insufficiency
  • Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
  • History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
  • Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
  • HIV+ patients
  • Pregnant or lactating females.
Female
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00035100
External Affairs, Novartis
CEPO906A2203
Novartis
 
Study Chair: Novartis Novartis
Novartis
September 2009

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