EPO906 Phase I 6-arm Trial to Optimize Administration Exploring Single Dose Bolus and Continuous Infusion Over 1 or 5 Days Every 3 or 4 Weeks in Patients With Pretreated Advanced Colon Cancer With Nutritional Support Treatment and Intensive Management of Diarrhea
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colon Cancer
Both
Colon Cancer
Trial Information
EPO906 Phase I 6-arm Trial to Optimize Administration Exploring Single Dose Bolus and Continuous Infusion Over 1 or 5 Days Every 3 or 4 Weeks in Patients With Pretreated Advanced Colon Cancer With Nutritional Support Treatment and Intensive Management of Diarrhea
Inclusion Criteria:
1. Histologically confirmed, locally advanced, progressive or metastatic colon cancer,
up to 4 prior lines of prior chemotherapy, at least one measurable lesion according
to RECIST
2. Age ≥ 18 years
3. Life expectancy ≥ 12 weeks
4. WHO performance status of 0-1
5. Negative serum pregnancy test
6. Adequate hepatic or renal function and hematological parameters
Exclusion Criteria:
1. Brain metastases
2. Ileostomy or colonostomy
3. History of pelvic radiotherapy
4. Grade > 1 diarrhea at baseline
Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To identifymaximum tolerated dose (MTD)
Outcome Time Frame:
During cycle 1 and 2 (approx 6 to 8 wks)
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Royal London Hospital
Authority:
United States: Food and Drug Administration
Study ID:
CEPO906A2117
NCT ID:
NCT00969046
Start Date:
November 2003
Completion Date:
Related Keywords:
- Colon Cancer
- Colon cancer
- MTD
- DLT
- EPO906
- patupilone
- Colonic Neoplasms
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