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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate

Outcome Description:

tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).

Outcome Time Frame:

Every 2 cycles

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CEPO906A2203

NCT ID:

NCT00035100

Start Date:

September 2001

Completion Date:

Related Keywords:

  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • ovarian
  • ovary
  • peritoneal cancer
  • fallopian cancer
  • cancer
  • tumor
  • tumour
  • neoplasm
  • carcinoma
  • intravenous
  • epothilone
  • Neoplasms
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

Novartis Investigative SiteNew Brunswick, New Jersey  08901