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

This study has been completed.
Sponsor:
Information provided by:
Cell Therapeutics
ClinicalTrials.gov Identifier:
NCT00291785
First received: February 14, 2006
Last updated: June 6, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Colorectal Cancer
 Drug: CT-2106
Drug: Folinic acid
Drug: 5-FU (fluorouracil)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cell Therapeutics:

Primary Outcome Measures:
  • Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity [ Time Frame: Each cycle ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: January 2004
Study Completion Date: September 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291785

Locations
Italy
Policlinico Universitario "A.Gemelli"
Rome, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Sponsors and Collaborators
Cell Therapeutics
Investigators
Principal Investigator: Barone C., M.D. Policlinico Universitario "A.Gemelli"
  More Information

No publications provided

Responsible Party: Igor Gorbatchevsky,M.D., Cell Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00291785     History of Changes
Other Study ID Numbers: CAM201
Study First Received: February 14, 2006
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cell Therapeutics:
colorectal cancer
camptothecin

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Leucovorin
Folic Acid
Levoleucovorin
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013