Status:
COMPLETED
Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer
Lead Sponsor:
CTI BioPharma
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal tissues....
Eligibility Criteria
Inclusion
- Histologically proven metastatic colorectal adenocarcinoma, failing one prior treatment containing oxaliplatin plus 5-FU/FA
- At least one measurable lesion according to RECIST criteria for both Phase I and II
- ECOG performance status 0 or 1
- Adequate hematologic, renal and hepatic function
- Wash out period of at least 4 weeks from surgery, 4 weeks from radiotherapy
Exclusion
- Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
- Pregnant or lactating patients
- Prior treatment with camptothecins
- Presence or history of CNS metastasis or carcinomatous leptomeningitis
- Current active infection per investigator assessment
- Unresolved bowel obstruction or partial obstruction, uncontrolled Crohn's disease or ulcerative colitis
- Current history of chronic diarrhea greater than or equal to grade 1 (CTCAE version 3)
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00291785
Start Date
January 1 2004
End Date
September 1 2008
Last Update
June 8 2011
Active Locations (2)
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1
Policlinico Universitario "A.Gemelli"
Rome, Italy
2
Istituto Clinico Humanitas
Rozzano, Italy