EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
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
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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
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 Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013