Colorectal CarcinomaPhase 2NCT00176774
Irinotecan, 5-Fluorouracil, and Leucovorin in Colorectal Carcinoma
A Phase 2 study testing Irinotecan, 5-Fluorouracil and Leucovorin in people with Colorectal Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This study will examine an investigational (experimental) agent Tetrathiomolybdate (TM) combined with the chemotherapy drugs Irinotecan, 5-Fluorouracil (5-FU) and Leucovorin (LV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Irinotecan, 5-Fluorouracil and Leucovorin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Apr 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
- Conditions
- Colorectal Carcinoma
- Being tested
- Irinotecan, 5-Fluorouracil, Leucovorin, Tetrathiomolybdate
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
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.
5-FluorouracilDrug
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.
LeucovorinDrug
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.
TetrathiomolybdateDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
OBJECTIVES
Measured: 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.
Measured: 12 months
Toxicity
Measured: 12 months
Secondary outcomes (3)
To evaluate the progression free survival in patients with metastatic colorectal cancer when treated with this regimen.
Measured: 24 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.
Measured: 12 months
To determine the success rate of TM leading to target levels of copper depletion in patients treated concurrently with chemotherapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2001
- Primary completionFeb 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Mark Zalupski, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176774
- Sponsor's protocol ID
- UMCC 0075
- Status last verified
- Feb 2012
- First submitted
- 12 Sep 2005
- Last updated
- 7 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Irinotecan, 5-Fluorouracil, and Leucovorin Combined With the Anti-Angiogenesis Agent Tetrathiomolybdate in Metastatic Colorectal Carcinoma (UMCC 0075)
- ClinicalTrials.gov ID
- NCT00176774
- Acronym / sponsor ID
- UMCC 0075
- Conditions
- Colorectal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Feb 2001
- Primary completion
- Feb 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrinotecanIrinotecan 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-FluorouracilIrinotecan 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 | – |
| LeucovorinIrinotecan 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 | – |
| Tetrathiomolybdateone 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. | Drug | – |
Primary outcome
OBJECTIVES
Time frame: 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
Toxicity
Time frame: 12 months
3 secondary outcomes
To evaluate the progression free survival in patients with metastatic colorectal cancer when treated with this regimen.
Time frame: 24 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
To determine the success rate of TM leading to target levels of copper depletion in patients treated concurrently with chemotherapy
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
Related trials for Colorectal Carcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Zalupski, M.D. principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan, 5-Fluorouracil and Leucovorin in people with Colorectal Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OBJECTIVES (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2012.