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Irinotecan, 5-Fluorouracil, and Leucovorin in Colorectal Carcinoma

NCT00176774 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-02-07

No results posted yet for this study

Summary

This study will examine an investigational (experimental) agent Tetrathiomolybdate (TM) combined with the chemotherapy drugs Irinotecan, 5-Fluorouracil (5-FU) and Leucovorin (LV). This study will evaluate the safety and tolerability of the combination of these drugs when they are used in the treatment of metastatic colorectal cancer.

This is a pilot clinical trial which will be studying the reactions of the patient's body and tumor to the experimental treatment described above. The purpose of this study is to find out what kind of side effects this experimental treatment causes and see how often these side effects occur.

Conditions

  • Colorectal Carcinoma

Interventions

DRUG

Irinotecan

Irinotecan by intravenous infusion (needle in a vein in your arm) over 90 minutes immediately followed by intravenous LV and 5-FU weekly for 4 weeks (days 1, 8, 15 and 22) followed by two weeks of no treatment.

DRUG

5-Fluorouracil

Irinotecan by intravenous infusion (needle in a vein in your arm) over 90 minutes immediately followed by intravenous LV and 5-FU weekly for 4 weeks (days 1, 8, 15 and 22) followed by two weeks of no treatment.

DRUG

Leucovorin

Irinotecan by intravenous infusion (needle in a vein in your arm) over 90 minutes immediately followed by intravenous LV and 5-FU weekly for 4 weeks (days 1, 8, 15 and 22) followed by two weeks of no treatment.

DRUG

Tetrathiomolybdate

one 40 mg oral (by mouth) dose of TM three times a day with meals and one 60 mg oral dose (without food) at bedtime beginning at bedtime on day 1 of your first 6-week cycle of treatment. The between meal dose must be taken at least one hour before or one hour after a meal.

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Mark Zalupski, M.D. · University of Michigan Rogel Cancer Center

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
2001-02-28
Primary Completion
2004-02-29
Completion
2004-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00176774 on ClinicalTrials.gov