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
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 54
Study Start Date: September 2001
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPO906 Drug: epothilone b
Other Name: EPO906

  Eligibility

Ages Eligible for Study:   18 Years and older
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
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, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
Novartis Investigative Site
New Brunswick, New Jersey, United States, 08901
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands, 1066 CX
Novartis Investigative Site
Enschede, Netherlands, 7513 ER
Novartis Investigative Site
Zwolle, Netherlands, 8025 AB
Slovakia
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00035100     History of Changes
Other Study ID Numbers: CEPO906A2203
Study First Received: May 2, 2002
Last Updated: April 13, 2012
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:
Neoplasms
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Epothilone B
Epothilones
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014