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Combination Chemotherapy in Treating Patients Who Have Advanced Solid Tumors

This study has been completed.
Study NCT00020488.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Combination Chemotherapy in Treating Patients Who Have Advanced Solid Tumors
Official Title  A Phase I & Pharmacologic Trial Of Sequential Irinotecan As A 24-Hour IV Infusion, Leucovorin, & Flurouracil As A 48-Hour IV Infusion In Adult Cancer Patients
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.

Detailed Description

OBJECTIVES:

  • Determine the recommended phase II dose of irinotecan, leucovorin calcium, and fluorouracil in patients with advanced solid tumors.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the pharmacokinetic and pharmacodynamic profiles of irinotecan and fluorouracil in patients treated with this regimen.
  • Determine the correlation of polymorphisms in the promoter region of the thymidylate synthase gene with clinical toxicity and response in patients treated with this regimen.
  • Determine the correlation of polymorphisms in the uridine diphosphate glucuronosyltransferase 1A1 gene promoter with the extent of SN-38 glucuronidation and severity of diarrhea in patients treated with this regimen.
  • Assess any anti-tumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of irinotecan and fluorouracil.

Patients receive irinotecan IV continuously over 24 hours on days 1 and 15 and leucovorin calcium IV over 30 minutes followed by fluorouracil IV continuously over 48 hours on days 2 and 16. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. Once the MTD of irinotecan has been determined, additional cohorts receive escalating doses of fluorouracil until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 20 months.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Unspecified Adult Solid Tumor, Protocol Specific
Intervention  Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  February 2001
Completion Date
Eligibility Criteria 

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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00020488
Organization ID CDR0000068548
Secondary IDs †† NCI-01-C-0082, MB-NAVY-00-02, MB-NAVY-B00-038
Study Sponsor  National Cancer Institute (NCI)
Collaborators ††
Investigators 
Study Chair:     Eva Szabo, MD     National Cancer Institute (NCI)    
Information Provided By National Cancer Institute (NCI)
Verification Date September 2003
First Received Date  July 11, 2001
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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