Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00009815
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing etoposide, leucovorin calcium and tegafur-uracil in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Pittsburgh.
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 chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors. 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?
- etoposide, leucovorin calcium 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 metastases CT scan required if clinical suspicion of CNS metastases
PATIENT CHARACTERISTICS: Age: 18 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 upper limit of normal (ULN) AST no greater than 1.5 times ULN No acute hepatitis Renal: Not specified Cardiovascular: No unstable cardiac disease No history of cardiac arrhythmia (treated or untreated) No new onset crescendo or rest angina (stable exertional angina allowed) Pulmonary: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception at least 1 week prior to, during, and for at least 2 weeks after study No known hypersensitivity to fluorouracil-uracil or leucovorin calcium No grade 2 or greater nausea/vomiting or diarrhea No significant neurological or psychiatric condition, including psychotic disorders, dementia, or seizures No active serious infection or septicemia No severe gastrointestinal bleeding No other serious illness or significant medical condition that would preclude study No psychological, familial, or sociological condition that would preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered No more than 1 prior chemotherapy regimen Prior fluorouracil and taxanes allowed Prior parenteral etoposide allowed Endocrine therapy: No concurrent anti-cancer hormonal agents Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Prior radiotherapy to brain metastases allowed if stable neurological status achieved within 4 weeks of treatment No concurrent radiotherapy except for palliation of bone or brain metastases or pathological fractures of known lytic disease Surgery: Not specified Other: At least 3 weeks since prior investigational drugs and recovered No other concurrent anticancer drugs No other concurrent investigational therapy No concurrent halogenated antiviral agents such as lodenosine, fialuridine, clevudine, emtricitabine, or sorivudine No concurrent antiarrhythmic medication
About this study
Official title: Phase I Study Of Oral Etoposide 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 chemotherapy drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of etoposide when combined with fixed- dose fluorouracil-uracil plus leucovorin calcium in patients with advanced solid tumors. II. Determine possible side effects and toxicity of this regimen in these patients.
OUTLINE: This is a dose escalation study of etoposide. Patients receive oral etoposide daily on days 1-10 and oral fluorouracil-uracil plus oral leucovorin calcium twice a day on days 1-21. Treatment repeats every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity. Patients are followed at 2 months and then periodically for survival.
PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
- Being tested
- etoposide, 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.
etoposideDrug
tegafur-uracilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2004 (estimated)
- Study startDec 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Laura A. Pollice, University of Pittsburgh
- Investigators
- Chandra P. Belani, MD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00009815
- Sponsor's protocol ID
- 98-013
- Other IDs
- CDR0000068412, PCI-IRB-990923, NCI-G00-1902
- Status last verified
- Dec 2013
- First submitted
- 2 Feb 2001
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Of Oral Etoposide In Combination With ORZEL (UFT + Leucovorin) For Advanced Non-Hematological Malignancies
- ClinicalTrials.gov ID
- NCT00009815
- Acronym / sponsor ID
- 98-013
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 1999
- First posted
- 20 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 chemotherapy drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of etoposide when combined with fixed- dose fluorouracil-uracil plus leucovorin calcium in patients with advanced solid tumors. II. Determine possible side effects and toxicity of this regimen in these patients.
OUTLINE: This is a dose escalation study of etoposide. Patients receive oral etoposide daily on days 1-10 and oral fluorouracil-uracil plus oral leucovorin calcium twice a day on days 1-21. Treatment repeats every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity. Patients are followed at 2 months and then periodically for survival.
PROJECTED ACCRUAL: Approximately 25-30 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 |
|---|---|---|
| etoposide | Drug | – |
| leucovorin calcium | Drug | – |
| tegafur-uracil | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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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.
Chandra P. Belani, MD study chair
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing etoposide, leucovorin calcium 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.