UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors

NCT00042861 | Completed Phase 1

• 4 other identifiers: CDR0000069478NCI-NAVY-01-04NCI-5535NCI-02-C-0222
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining UCN-01, fluorouracil, and leucovorin in treating patients who have metastatic or unresectable solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

7-hydroxystaurosporine DRUG

fluorouracil DRUG

leucovorin calcium DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor that is metastatic or unresectable and for which no standard curative or palliative measures exist or are effective * No brain metastases or primary CNS malignancy 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 1.5 mg/dL * AST and ALT no greater than 3 times upper limit of normal Renal * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular * No known active coronary artery disease Pulmonary * No pulmonary dysfunction Other * HIV negative * No history of unusually severe and/or prolonged toxicity during prior therapy with fluorouracil (5-FU) or 5-FU prodrugs * No diabetes mellitus requiring insulin or oral hypoglycemic therapy * No ongoing or active infection requiring IV antibiotics * No other serious concurrent medical illness that would preclude study * No psychiatric illness or social situations that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior immunotherapy and recovered * No concurrent cytokines during the first course of therapy Chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy * No concurrent systemic corticosteroids Radiotherapy * At least 2 weeks since prior radiotherapy and recovered * No prior pulmonary or mediastinal radiation exceeding 40 Gy Surgery * Recovered from prior surgery Other * No other concurrent investigational agents * No concurrent cimetidine * No concurrent sorivudine or brivudine

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Interventions

7-hydroxystaurosporine; Fluorouracil; Leucovorin

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Jean L. Grem, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 5, 2002
• First Posted: January 27, 2003
• Study Start: August 1, 2002
• Last Updated: April 30, 2015

Record last verified: 2003-04

Locations

US (1)