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

February 14, 2006
February 15, 2006
June 8, 2011
January 2004
August 2007   (Final data collection date for primary outcome measure)
Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity [ Time Frame: Each cycle ]
Not Provided
Complete list of historical versions of study NCT00291785 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer
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
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.
Not Provided
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Cancer
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2008
August 2007   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Igor Gorbatchevsky,M.D., Cell Therapeutics, Inc.
CTI BioPharma
Not Provided
Principal Investigator: Barone C., M.D. Policlinico Universitario "A.Gemelli"
CTI BioPharma
June 2011

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