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Phase I Study Of Oral Etoposide In Combination With ORZEL (UFT + Leucovorin) For Advanced Non-Hematological Malignancies

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study Of Oral Etoposide In Combination With ORZEL (UFT + Leucovorin) For Advanced Non-Hematological Malignancies

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Chandra P. Belani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh


United States: Federal Government

Study ID:




Start Date:

December 1999

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213