Colonic Neoplasms, Colorectal Neoplasms
Conditions
Keywords
colon, rectum, colorectal, rectal, 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 colorectal cancer.
Interventions
DRUGepothilone b
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients must meet the following criteria to be eligible for the study: * Histologically or cytologically documented evidence of colorectal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation) * The patient should have failed or progressed on no more than two prior chemotherapies for metastatic disease (the prior chemotherapy must have included a fluoropyrimidine and either Irinotecan or oxaliplatin, or any combination of these agents, with the last chemotherapy having contained Irinotecan or oxaliplatin) * Patients who have received only adjuvant therapy for their disease are eligible, as long as they have relapsed within six months of completing such therapy and that therapy contained 5-FU and Irinotecan or oxaliplatin administered in combination as part of an investigational protocol * Must have a life expectancy of greater than three (3) months.
Exclusion criteria
The following patients are not eligible for the study: * Patients with symptomatic CNS metastases or leptomeningeal involvement * Patients with unresolved bowel obstruction * Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1 * Patients with severe cardiac insufficiency * Patients who have undergone major surgery for any cause less than 4 weeks prior to study entry * Patients with radiation therapy or chemotherapy within the last four weeks * 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 |
|---|---|
| Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | — |
| Overall survival | — |
Countries
United States
Outcome results
None listed