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Irinotecan, 5-Fluorouracil, and Leucovorin in Colorectal Carcinoma

This study has been completed.
Sponsor:
Information provided by:
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00176774
First received: September 12, 2005
Last updated: February 5, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Carcinoma
 Drug: Irinotecan
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: Tetrathiomolybdate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Trial of Irinotecan, 5-Fluorouracil, and Leucovorin Combined With the Anti-Angiogenesis Agent Tetrathiomolybdate in Metastatic Colorectal Carcinoma (UMCC 0075)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • OBJECTIVES [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the progression free survival in patients with metastatic colorectal cancer when treated with this regimen. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To determine the success rate of TM leading to target levels of copper depletion in patients treated concurrently with chemotherapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2001
Study Completion Date: April 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176774

Locations
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Mark Zalupski, M.D. University of Michigan Cancer Center
  More Information

No publications provided

Responsible Party: Dr. Mark Zalupski, University of Michigan Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00176774     History of Changes
Other Study ID Numbers: UMCC 0075
Study First Received: September 12, 2005
Last Updated: February 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
 Tetrathiomolybdate
Irinotecan
Leucovorin
Molybdenum
Levoleucovorin
Angiogenesis Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013