Back to resultsPhase I/II CT 2106 and 5-FU/FA in Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
CT-2106
Folinic acid
5-FU (fluorouracil)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, camptothecin
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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)
Sites / Locations
- Policlinico Universitario "A.Gemelli"
- Istituto Clinico Humanitas
Outcomes
Primary Outcome Measures
Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00291785
Brief Title
Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer
Official Title
Phase I/II Study of CT-2106 in Combination With Infusional 5-fluorouracil/Folinic Acid (5-FU/FA)(de Gramont Schedule) as Second Line in Patients With Metastatic Colorectal Cancer Failing an Oxaliplatin Plus 5-FU/FA Regimen
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
CTI BioPharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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. The objective of this study is to determine the dose limiting toxicities, safety profile and antitumor activity of CT-2016 in combination with 5-FU and folic acid for the treatment of colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, camptothecin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CT-2106
Intervention Description
CT-2106 as 10 minute infusion on days 1, 15 & 29 of each 42-day cycle
Intervention Type
Drug
Intervention Name(s)
Folinic acid
Intervention Description
Folinic acid 200 mg IV 1 hour after CT-2106 infusion on days 1, 2, 15, 16, 29 and 30
Intervention Type
Drug
Intervention Name(s)
5-FU (fluorouracil)
Intervention Description
5-FU following CT-2106 and folinic acid infusions @ 400 mg/m² IV bolus then 5-FU 600 mg/m² as a 22 hour IV infusion on Days 1, 2, 15, 16, 29, and 30.
Primary Outcome Measure Information:
Title
Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity
Time Frame
Each cycle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barone C., M.D.
Organizational Affiliation
Policlinico Universitario "A.Gemelli"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Universitario "A.Gemelli"
City
Rome
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer
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