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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

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: CT-2106 Drug: Folinic acid Drug: 5-FU (fluorouracil) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity [ Time Frame: Each cycle ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00291785

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Policlinico Universitario "A.Gemelli"
Rome, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Sponsors and Collaborators
CTI BioPharma
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Principal Investigator: Barone C., M.D. Policlinico Universitario "A.Gemelli"

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Responsible Party: Igor Gorbatchevsky,M.D., Cell Therapeutics, Inc. Identifier: NCT00291785     History of Changes
Other Study ID Numbers: CAM201
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011
Keywords provided by CTI BioPharma:
colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Folic Acid
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Growth Substances