Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00003925
Combination Chemotherapy In Treating Patients With Advanced Cancer
A Phase 1 study testing gemcitabine hydrochloride, leucovorin calcium and tegafur-uracil in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
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 I trial to study the effectiveness of combining gemcitabine, fluorouracil-uracil and leucovorin in treating patients who have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- gemcitabine hydrochloride, leucovorin calcium and tegafur-uracil
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 1998to Aug 2007
- Phase
- Phase 1
- 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
DISEASE CHARACTERISTICS:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
About this study
Official title: Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin
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 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.
Read the detailed description
OBJECTIVES:
- 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.
- Being tested
- gemcitabine hydrochloride, leucovorin calcium, tegafur-uracil
- Keywords
- unspecified adult solid tumor, protocol specific
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 posted2 May 2003 (estimated)
- Study startMay 1998
- Primary completionAug 2007
- Study completionAug 2007
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 Unspecified Adult Solid Tumor, Protocol SpecificStudies 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 1
- Primary purpose
- Treatment
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Philip A. Philip, MD, PhD, FRCP, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003925
- Sponsor's protocol ID
- CDR0000067112
- Other IDs
- P30CA022453, WSU-D-1641, WSU-04-28-98-M02-FB, NCI-G99-1526
- Status last verified
- Apr 2013
- First submitted
- 1 Nov 1999
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17414457Philip 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.
PubMed 10442378
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin
- ClinicalTrials.gov ID
- NCT00003925
- Acronym / sponsor ID
- CDR0000067112
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1998
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 2 May 2003 (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 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
OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, 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 |
|---|---|---|
| gemcitabine hydrochloride | Drug | – |
| 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 8 Apr 2013.
- Results publication: PubMed 17414457El-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.
- Results publication: PubMed 10442378Philip 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.
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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.
Philip A. Philip, MD, PhD, FRCP study chair
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gemcitabine hydrochloride, leucovorin calcium and tegafur-uracil in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Barbara Ann Karmanos Cancer Institute 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?
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 8 Apr 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 NCT00003925, 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 8 Apr 2013.