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Irinotecan, 5-Fluorouracil, and Leucovorin in Colorectal Carcinoma

Information source: University of Michigan Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Carcinoma

Intervention: Irinotecan (Drug); 5-Fluorouracil (Drug); Leucovorin (Drug); Tetrathiomolybdate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Michigan Cancer Center

Official(s) and/or principal investigator(s):
Mark Zalupski, M.D., Principal Investigator, Affiliation: University of Michigan Cancer Center

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.

Clinical Details

Official title: A Pilot Trial of Irinotecan, 5-Fluorouracil, and Leucovorin Combined With the Anti-Angiogenesis Agent Tetrathiomolybdate in Metastatic Colorectal Carcinoma (UMCC 0075)

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

OBJECTIVES

To determine the tolerability and toxicity of tetrathiomolybdate (TM) in combination with irinotecan, 5-fluorouracil (5-FU), and leucovorin (LV) in metastatic colorectal cancer.

Toxicity

Secondary outcome:

To evaluate the progression free survival in patients with metastatic colorectal cancer when treated with this regimen.

To determine the tolerability and toxicity of tetrathiomolybdate (TM) in combination with irinotecan, 5-fluorouracil (5-FU), and leucovorin (LV) in metastatic colorectal cancer.

To determine the success rate of TM leading to target levels of copper depletion in patients treated concurrently with chemotherapy

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must have histologically proven adenocarcinoma primary to the colon or

rectum and clinical or pathologic evidence of distant metastasis.

- Patients may have received adjuvant chemotherapy and/or one regimen of chemotherapy

for metastatic disease. Patients must not have been previously treated with the combination of irinotecan/5-FU/LV.

- Patients must be past their 18th birthday at the time of enrollment.

- Patients must have a performance status of 0-2 at the time of registration.

- Patients must have a life expectancy of > 3 months.

- If patients have undergone recent surgery, they must have fully recovered from the

effects of that surgery prior to enrollment.

- Patients must have a pretreatment leukocyte count > 3,000/l, absolute neutrophil

count >1500/l, hemoglobin >8 mg/dl, and platelet count of > 150,000/l within 2 weeks of enrollment.

- Patients must have adequate renal function, as documented by a serum creatinine < 2. 0

mg/dl, and have adequate hepatic function, as documented by a serum bilirubin < 1. 1 mg/dl within 2 weeks of enrollment. Exclusion Criteria:

- Patients must not have active infection.

- Patients must have no serious medical or psychiatric illness, other than that treated

by this study, which would limit the ability of the patient to receive protocol therapy or give informed consent.

- Patients must not have a history of active malignancy, other than that treated by

this study, within the 12 months preceding enrollment.

- Pregnant or lactating women may not participate. Women of reproductive age must

undergo a serum pregnancy test within 14 days of enrollment. Men and women of reproductive potential must use an effective contraceptive method during the study.

- There must be no plans for the patient to receive concomitant antineoplastic therapy

while on this protocol. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Locations and Contacts

University of Michigan Cancer Center, Ann Arbor, Michigan 48109, United States
Additional Information

Starting date: February 2001
Last updated: February 5, 2012

Page last updated: August 23, 2015

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