EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00035100
First received: May 2, 2002
Last updated: April 13, 2012
Last verified: April 2012

May 2, 2002
April 13, 2012
September 2001
June 2003   (final data collection date for primary outcome measure)
Tumor response rate [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
Not Provided
Complete list of historical versions of study NCT00035100 on ClinicalTrials.gov Archive Site
  • Time to disease progression [ Time Frame: from start of treatment to documented disease progression, death from study indication, or the date of last follow-up ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: measured from the start of treatment to the date of death or the last date the patient was known to be alive. ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
    duration of response in patients with complete response (CR) or partial response (PR)
  • recording all adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
    Safety and tolerability of patupilone by monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry and urine lalues, vital signs, ECG and physical examinations
  • pharmacogenetic analyses with blood and tumor samples from these patients [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
Drug: epothilone b
Other Name: EPO906
Experimental: EPO906
Intervention: Drug: epothilone b
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
Not Provided
June 2003   (final data collection date for primary outcome measure)

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 and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Netherlands,   Slovakia,   United Kingdom
 
NCT00035100
CEPO906A2203
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2012

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