- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00176774
Irinotecan, 5-Fluorouracil, and Leucovorin in Colorectal Carcinoma
A Pilot Trial of Irinotecan, 5-Fluorouracil, and Leucovorin Combined With the Anti-Angiogenesis Agent Tetrathiomolybdate in Metastatic Colorectal Carcinoma (UMCC 0075)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
OBJECTIVES
Time Frame: 12 months
|
12 months
|
To determine the tolerability and toxicity of tetrathiomolybdate (TM) in combination with irinotecan, 5-fluorouracil (5-FU), and leucovorin (LV) in metastatic colorectal cancer.
Time Frame: 12 months
|
12 months
|
Toxicity
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the tolerability and toxicity of tetrathiomolybdate (TM) in combination with irinotecan, 5-fluorouracil (5-FU), and leucovorin (LV) in metastatic colorectal cancer.
Time Frame: 12 months
|
12 months
|
To evaluate the progression free survival in patients with metastatic colorectal cancer when treated with this regimen.
Time Frame: 24 months
|
24 months
|
To determine the success rate of TM leading to target levels of copper depletion in patients treated concurrently with chemotherapy
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Carcinoma
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Topoisomerase Inhibitors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Micronutrients
- Vitamins
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Chelating Agents
- Sequestering Agents
- Fluorouracil
- Leucovorin
- Irinotecan
- Tetrathiomolybdate
Other Study ID Numbers
- UMCC 0075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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