Combination Chemotherapy In Treating Patients With Advanced Cancer
NCT ID: NCT00003925
Last Updated: 2013-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
36 participants
INTERVENTIONAL
1998-05-31
2007-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine, fluorouracil-uracil and leucovorin in treating patients who have advanced cancer that has not responded to previous therapy.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Determine the maximum tolerated doses of gemcitabine, fluorouracil-uracil (UFT), and leucovorin calcium in patients with advanced refractory cancer.
* Assess the toxicity of this combination regimen in this patient population.
* Evaluate this regimen in terms of response rate, response duration, and overall survival in these patients.
OUTLINE: This is a dose escalation study of gemcitabine and fluorouracil-uracil.
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients receive oral leucovorin calcium immediately followed by oral fluorouracil-uracil (UFT) three times a day on days 1-21. Courses are repeated every 28 days. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine and UFT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
gemcitabine hydrochloride
leucovorin calcium
tegafur-uracil
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically or cytologically confirmed malignancy refractory to existing chemotherapy or for which no standard therapy exists
* Evaluable disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* SWOG 0-2
Life expectancy:
* Greater than 3 months
Hematopoietic:
* Absolute neutrophil count greater than 1,500/mm3
* Platelet count greater than 100,000/mm3
* Hemoglobin greater than 8.0 mg/dL
Hepatic:
* Bilirubin less than 2.0 mg/dL
* AST less than 3.0 times upper limit of normal
Renal:
* Creatinine no greater than 2.0 mg/dL
Other:
* No active infection requiring antibiotics
* Not pregnant or nursing
* Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 3 weeks since prior systemic cytotoxic chemotherapy (including fluorouracil) and recovered
* No prior gemcitabine
Endocrine therapy:
* Prior hormonal therapy allowed
* No concurrent hormonal contraception
Radiotherapy:
* At least 3 weeks since prior radiotherapy to large areas of active bone marrow and recovered
Surgery:
* Prior major surgery allowed and recovered
Other:
* No prior or concurrent antiviral nucleosides
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Barbara Ann Karmanos Cancer Institute
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Philip A. Philip, MD, PhD, FRCP
Role: STUDY_CHAIR
Barbara Ann Karmanos Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
El-Rayes BF, Zalupski M, Shields AF, Manza SG, LoRusso P, Philip PA. A phase I study of gemcitabine and uracil-ftorfar (UFT)/leucovorin. Am J Clin Oncol. 2007 Apr;30(2):101-5. doi: 10.1097/01.coc.0000251223.98193.f4.
Philip PA, Ibrahim D, Zalupski M, Arlauskas P, Shields A. Gemcitabine and UFT plus oral calcium folinate: phase I study. Oncology (Williston Park). 1999 Jul;13(7 Suppl 3):116-9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WSU-D-1641
Identifier Type: -
Identifier Source: secondary_id
WSU-04-28-98-M02-FB
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1526
Identifier Type: -
Identifier Source: secondary_id
CDR0000067112
Identifier Type: -
Identifier Source: org_study_id