Combination Chemotherapy in Treating Patients Who Have Advanced Solid Tumors

NCT00020488 | Completed Phase 1

• 4 other identifiers: CDR0000068548NCI-01-C-0082MB-NAVY-00-02MB-NAVY-B00-038
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

FOLFIRI regimen DRUG

fluorouracil DRUG

irinotecan hydrochloride 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 advanced solid tumor that has failed standard therapy or for which no standard therapy exists * Locally advanced, unresectable, primary or recurrent disease OR * Metastatic disease * Previously untreated disease allowed provided this regimen represents reasonable first-line therapy * No leukemia or lymphoma * No primary CNS malignancy or CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.6 mg/dL * AST/ALT no greater than 4 times upper limit of normal Renal: * Creatinine no greater than 1.6 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No other serious concurrent illness that would preclude study * No active infection requiring IV antibiotics * No known hypersensitivity to irinotecan * No marked intolerance to fluorouracil PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 4 weeks since prior immunotherapy and recovered Chemotherapy: * More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered * Prior short-infusion irinotecan allowed * Prior fluorouracil allowed Endocrine therapy: * Not specified Radiotherapy: * At least 2 weeks since prior radiotherapy and recovered * At least 8 weeks since prior strontium chloride Sr 89 Surgery: * Recovered from prior surgery Other: * No concurrent cimetidine

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

Fluorouracil; Irinotecan; Leucovorin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Eva Szabo, 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: July 11, 2001
• First Posted: January 27, 2003
• Study Start: February 1, 2001
• Last Updated: April 30, 2015

Record last verified: 2003-09

Locations

US (1)