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

June 6, 2011 updated by: CTI BioPharma

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.

Study Overview

Status

Completed

Conditions

Colorectal Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Rome, Italy
    - Policlinico Universitario "A.Gemelli"
  - Rozzano, Italy
    - Istituto Clinico Humanitas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity Time Frame: Each cycle	Each cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CTI BioPharma

Investigators

Principal Investigator: Barone C., M.D., Policlinico Universitario "A.Gemelli"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (ACTUAL)

August 1, 2007

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria