Colorectal CancerPhase 2NCT00004860
Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
A Phase 2 study testing leucovorin calcium and tegafur-uracil in people with Colorectal Cancer, run by Eastern Cooperative Oncology Group at 51 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in treating elderly patients who have metastatic… Read more about this study
- Who is it for?
- Ages 75 to 120 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- leucovorin calcium and tegafur-uracil
- How many people
- Not given
- Where
- 51 sitesin 2 countries
- Study dates
- 9 Oct 2000to Oct 2005
- 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 75 to 120 years
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS: Histologically confirmed metastatic colorectal adenocarcinoma Measurable disease
PATIENT CHARACTERISTICS: Age: 75 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST or ALT no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Other: No serious infection No other serious underlying medical condition that would preclude protocol therapy No known hypersensitivity to fluorouracil-uracil or leucovorin calcium
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior adjuvant immunotherapy for colorectal cancer No concurrent immunotherapy Chemotherapy: At least 6 months since prior adjuvant chemotherapy for colorectal cancer No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: See Disease Characteristics At least 6 months since prior adjuvant radiotherapy for colorectal cancer Prior radiotherapy for locally symptomatic disease allowed Surgery: Prior surgery allowed Other: No prior therapy for metastatic disease No other concurrent investigational drugs No concurrent halogenated antiviral agents (e.g., lodenosine, fialuridine, FMAU, emtricitabine, and sorivudine)
Trial locations and contacts
51 sites in 2 countries.
51 sites in 2 countries
United States49 sites
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
New England Medical Center Hospital
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 11209
Veterans Affairs Medical Center - Cleveland
Cleveland, Ohio, 44106
CCOP - Columbus
Columbus, Ohio, 43206
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
CCOP - Evanston
Evanston, Illinois, 60201
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
Veterans Affairs Medical Center - Gainsville
Gainesville, Florida, 32608-1197
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, 15240
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
University of Rochester Cancer Center
Rochester, New York, 14642
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
Stanford University Medical Center
Stanford, California, 94305-5408
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, 33612
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
CCOP - Sooner State
Tulsa, Oklahoma, 74136
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
Puerto Rico2 sites
MBCCOP - San Juan
San Juan, 00927-5800
Veterans Affairs Medical Center - San Juan
San Juan, 00927-5800
About this study
Official title: A Phase II Study of ORZEL (UFT + Leucovorin) in Elderly (at Least 75 Years Old) Patients With Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in treating elderly patients who have metastatic colorectal cancer.
Read the detailed description
OBJECTIVES: I. Determine the response rate of elderly patients with metastatic colorectal cancer treated with fluorouracil-uracil and leucovorin calcium (Orzel). II. Evaluate the toxicity profile of this regimen in this patient population. III. Compare response rates obtained in this study with those observed in recent phase III studies in younger patients.
OUTLINE: Patients receive oral fluorouracil-uracil and oral leucovorin calcium (Orzel) every 8 hours for 28 days. Courses repeat every 35 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 1 year.
- Conditions
- Colorectal Cancer
- Being tested
- leucovorin calcium, tegafur-uracil
- Keywords
- stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tegafur-uracilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2004 (estimated)
- Study start9 Oct 2000
- Primary completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Howard S. Hochster, MD, Study chair, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004860
- Sponsor's protocol ID
- CDR0000067511
- Other IDs
- E-1299
- Status last verified
- Jun 2023
- First submitted
- 7 Mar 2000
- Last updated
- 15 Jun 2023
- Results posted
- No
Publications
Hochster HS, Luo W, Popa EC, Lyman BT, Mulcahy M, Beatty PA, Benson AB. Phase II study of uracil-tegafur with leucovorin in elderly (> or = 75 years old) patients with colorectal cancer: ECOG 1299. J Clin Oncol. 2007 Dec 1;25(34):5397-402. doi: 10.1200/JCO.2006.10.4521.
PubMed 18048821Popa EC, Luo W, Hochster H, et al.: A phase II study of orzel (UFT+leucovorin) in elderly (=75 years old) patients with colorectal cancer: results of ECOG 1299. [Abstract] J Clin Oncol 23 (Suppl 16): A-3608, 273s, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of ORZEL (UFT + Leucovorin) in Elderly (at Least 75 Years Old) Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00004860
- Acronym / sponsor ID
- CDR0000067511
- Conditions
- Colorectal Cancer
- Keywords
- stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Oct 2000 (actual)
- Primary completion
- Oct 2005 (actual)
- First posted
- 12 Apr 2004 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in treating elderly patients who have metastatic colorectal cancer.
Detailed description
OBJECTIVES: I. Determine the response rate of elderly patients with metastatic colorectal cancer treated with fluorouracil-uracil and leucovorin calcium (Orzel). II. Evaluate the toxicity profile of this regimen in this patient population. III. Compare response rates obtained in this study with those observed in recent phase III studies in younger patients.
OUTLINE: Patients receive oral fluorouracil-uracil and oral leucovorin calcium (Orzel) every 8 hours for 28 days. Courses repeat every 35 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 75 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| leucovorin calcium | Drug | – |
| tegafur-uracil | Drug | – |
Primary outcome
Not reported in the source record.
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 15 Jun 2023.
- Results publication: PubMed 18048821Hochster HS, Luo W, Popa EC, Lyman BT, Mulcahy M, Beatty PA, Benson AB. Phase II study of uracil-tegafur with leucovorin in elderly (> or = 75 years old) patients with colorectal cancer: ECOG 1299. J Clin Oncol. 2007 Dec 1;25(34):5397-402. doi: 10.1200/JCO.2006.10.4521.
- Results publicationPopa EC, Luo W, Hochster H, et al.: A phase II study of orzel (UFT+leucovorin) in elderly (=75 years old) patients with colorectal cancer: results of ECOG 1299. [Abstract] J Clin Oncol 23 (Suppl 16): A-3608, 273s, 2005.
Related trials for Colorectal Cancer
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
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
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
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.
Howard S. Hochster, MD study chair
NYU Langone Health
51 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing leucovorin calcium and tegafur-uracil in people with Colorectal Cancer, run by Eastern Cooperative Oncology Group at 51 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Puerto Rico. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004860, which also lists 2 linked publications.
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 15 Jun 2023.