Fallopian Tube Neoplasms, Ovarian Neoplasms, Peritoneal Neoplasms
Conditions
Keywords
ovarian, ovary, peritoneal cancer, fallopian cancer, cancer, tumor, tumour, neoplasm, carcinoma, intravenous, epothilone
Brief summary
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.
Interventions
DRUGepothilone b
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response rate | Every 2 cycles | tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to disease progression | from start of treatment to documented disease progression, death from study indication, or the date of last follow-up | — |
| Overall survival | measured from the start of treatment to the date of death or the last date the patient was known to be alive. | — |
| Duration of response | Every 3 months | duration of response in patients with complete response (CR) or partial response (PR) |
| recording all adverse events (AEs) and serious adverse events (SAEs) | Every 3 months | 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 | Every 3 months | — |
Countries
Canada, Netherlands, Slovakia, United Kingdom, United States
Outcome results
None listed