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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00009828

Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors

A Phase 1 study testing leucovorin calcium, paclitaxel and tegafur-uracil in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Pittsburgh.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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 paclitaxel combined with fluorouracil-uracil and leucovorin in treating patients who have… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
leucovorin calcium, paclitaxel and tegafur-uracil
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 1999to not given
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 solid tumor for which no curative or effective therapy is available No symptomatic or uncontrolled brain or leptomeningeal metastasis Irradiated brain metastasis allowed if neurological status is stable 4 weeks after radiotherapy

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1,500/mm3 Hepatic: SGOT no greater than 1.5 times upper limit of normal (ULN) Bilirubin no greater than ULN No acute hepatitis Renal: Not specified Cardiovascular: No unstable cardiac disease requiring treatment No cardiac arrhythmia No new onset crescendo or rest angina Stable exertional angina allowed Neurological: No symptomatic peripheral neuropathy greater than grade 1 No significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 weeks following study No other serious illness or medical condition No active infection, including septicemia No severe gastrointestinal bleeding No hypersensitivity to leucovorin calcium or fluorouracil-uracil No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent colony-stimulating growth factors within 24 hours of fluorouracil-uracil Chemotherapy: No more than 1 prior regimen of chemotherapy Prior taxanes and fluorouracil allowed At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered No other concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy and recovered No concurrent anti-cancer hormonal agents Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Concurrent radiotherapy allowed for palliation of painful bone metastases, pathologic fractures of known lytic disease, or brain lesions Surgery: Not specified Other: At least 3 weeks since prior investigational drugs No concurrent antiarrhythmic medication No other concurrent investigational therapy No concurrent halogenated anti-viral agent (e.g., lodenosine, fialuridine, clevudine, emtricitabine, or sorivudine)

About this study

Official title: Phase I Study Of Weekly Paclitaxel In Combination With ORZEL (UFT + Leucovorin) For Advanced Non-Hematological Malignancies

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 paclitaxel combined with fluorouracil-uracil and leucovorin in treating patients who have solid tumors.

Read the detailed description

OBJECTIVES: I. Determine the maximum tolerated dose of weekly paclitaxel when combined with fluorouracil-uracil and leucovorin calcium in patients with solid tumors. II. Determine the side effects and toxicity of this regimen in these patients.

OUTLINE: This is a dose escalation study of paclitaxel. Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive oral fluorouracil-uracil and leucovorin calcium twice daily on days 2-6, 9-13, and 16-20. Treatment repeats every 4 weeks for up to 6 courses in the absence of progressive disease or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 2 months and then for survival.

PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.

Being tested
leucovorin calcium, paclitaxel, 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2004 (estimated)
  2. Study startDec 1999

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00009828
Sponsor's protocol ID
98-012
Other IDs
CDR0000068413, PCI-IRB-990929, NCI-G00-1903
Status last verified
Dec 2013
First submitted
2 Feb 2001
Last updated
19 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing leucovorin calcium, paclitaxel and tegafur-uracil in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Pittsburgh.

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: withdrawn, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?
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 19 Dec 2013.

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