Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

NCT00009815 | Withdrawn Phase 1

• 4 other identifiers: 98-013CDR0000068412PCI-IRB-990923NCI-G00-1902
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

etoposide DRUG

leucovorin calcium DRUG

tegafur-uracil DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Interventions

Etoposide; Leucovorin; Tegafur

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Chandra P. Belani, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: April 20, 2004
• Study Start: December 1, 1999
• Last Updated: December 19, 2013

Record last verified: 2013-12