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

NCT00291785 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-06-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • CTI BioPharma

    lead INDUSTRY

Principal Investigators

  • Barone C., M.D. · Policlinico Universitario "A.Gemelli"

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2007-08-31
Completion
2008-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00291785 on ClinicalTrials.gov