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

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 Intervention Phase
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Drug: epothilone b
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Maximum tolerated dose

Secondary Outcome Measures:
  • Time to progression
  • Overall survival

Estimated Enrollment: 48
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035100

Locations
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94116
United States, Connecticut
St. Francis Hospital
Hartford, Connecticut, United States, 06105
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89109
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Utah
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CEPO906A2203
Study First Received: May 2, 2002
Last Updated: November 18, 2009
ClinicalTrials.gov Identifier: NCT00035100     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
ovarian
ovary
peritoneal cancer
fallopian cancer
cancer
tumor
tumour
neoplasm
carcinoma
intravenous
epothilone

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Epothilone B
Ovarian Neoplasms
Digestive System Neoplasms
Epothilones
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Antimitotic Agents
Abdominal Neoplasms
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Tubulin Modulators
Peritoneal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009