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EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, 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: NCT00035100
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : April 16, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Drug: epothilone b Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2001
Actual Primary Completion Date : June 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: EPO906 Drug: epothilone b
Other Name: EPO906

Primary Outcome Measures :
  1. Tumor response rate [ Time Frame: Every 2 cycles ]
    tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).

Secondary Outcome Measures :
  1. 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 ]
  2. 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. ]
  3. Duration of response [ Time Frame: Every 3 months ]
    duration of response in patients with complete response (CR) or partial response (PR)

  4. recording all adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Every 3 months ]
    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

  5. pharmacogenetic analyses with blood and tumor samples from these patients [ Time Frame: Every 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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): NCT00035100

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United States, New Jersey
Novartis Investigative Site
New Brunswick, New Jersey, United States, 08901
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Novartis Investigative Site
Amsterdam, Netherlands, 1066 CX
Novartis Investigative Site
Enschede, Netherlands, 7513 ER
Novartis Investigative Site
Zwolle, Netherlands, 8025 AB
Novartis Investigative Site
Bratislava, Slovakia, 812 50
Novartis Investigative Site
Kosice, Slovakia, 04190
United Kingdom
Novartis Investigative Site
Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00035100    
Other Study ID Numbers: CEPO906A2203
First Posted: May 3, 2002    Key Record Dates
Last Update Posted: April 16, 2012
Last Verified: April 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
peritoneal cancer
fallopian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Epothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents