Clinical trial NCT00035126: EPO906 Therapy in Patients With Advanced Breast Cancer
Official title: An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: breast
cancer
tumor
tumour
intravenous
epothilone
taxane
anthracycline
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine whether the 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 breast cancer.


Eligibility criteria: Inclusion Criteria:

The following patients may be eligible for this study:

* Histologically or cytologically documented evidence of disease with at least one measurable lesion;
* Life expectancy of greater than three (3) months;
* Patients who have had only one prior therapy for metastatic disease;
* Patients who have received prior treatment with hormonal agents or who have had prior treatment regimens of radiotherapy in addition to one or no previous chemotherapy regimens are eligible;
* Patients who have had no prior therapy for metastatic disease, but who have received a taxane and an anthracycline (single or combination therapy) as adjuvant treatment, are eligible. For patients who have had previous radiation therapy to the target lesion(s), the lesion(s) must since have demonstrated progression.

Exclusion Criteria:

The following patients are not eligible for this study:

* Bone-only disease;
* Symptomatic pleural effusions;
* Symptomatic CNS metastases or leptomeningeal involvement;
* Any peripheral neuropathy or unresolved diarrhea greater than Grade 1;
* 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 ckin cancer or cervical cancer in situ;
* Active or suspected acute or chronic uncontrolled infection including abcesses or fistulae;
* HIV+ patients;
* Pregnant or lactating females;
* Patients who have had radiation, chemotherapy, or hormonal therapy within the last four (4) weeks excluding palliative radiotherapy to isolated peripheral bone metastases not being used as markers for efficacy;
* Patients taking Herceptin less than three (3) weeks prior to study start.

Primary outcomes:
measure: Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Every 8 weeks
Secondary outcomes:
measure: Time to progression
timeFrame: until disease progression, death or date of last follow-up
measure: Overall survival
timeFrame: date of death or last date patient was known to be alive
measure: Duration of overall response
timeFrame: every 8 weeks as clinically needed
measure: Safety of study drug
timeFrame: weekly for the first 8 weeks, then every other week
measure: pharmacokinectics of study drug
timeFrame: every 8 weeks
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey (CINJ)
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: