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Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00291785
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : June 8, 2011
Information provided by:
CTI BioPharma

Tracking Information
First Submitted Date  ICMJE February 14, 2006
First Posted Date  ICMJE February 15, 2006
Last Update Posted Date June 8, 2011
Study Start Date  ICMJE January 2004
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2008)
Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity [ Time Frame: Each cycle ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00291785 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: CT-2106
    CT-2106 as 10 minute infusion on days 1, 15 & 29 of each 42-day cycle
  • Drug: Folinic acid
    Folinic acid 200 mg IV 1 hour after CT-2106 infusion on days 1, 2, 15, 16, 29 and 30
  • Drug: 5-FU (fluorouracil)
    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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2008)
Original Enrollment  ICMJE
 (submitted: February 14, 2006)
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00291785
Other Study ID Numbers  ICMJE CAM201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Igor Gorbatchevsky,M.D., Cell Therapeutics, Inc.
Study Sponsor  ICMJE CTI BioPharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barone C., M.D. Policlinico Universitario "A.Gemelli"
PRS Account CTI BioPharma
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP