Combination Chemotherapy in Treating Patients Who Have Advanced Solid Tumors - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020488

Purpose

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.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium	Phase I

Study Type:	Interventional
Study Design:	Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Irinotecan U 101440E Irinotecan hydrochloride Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

February 2001

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020488

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Eva Szabo, MD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068548, NCI-01-C-0082, MB-NAVY-00-02, MB-NAVY-B00-038
Study First Received:	July 11, 2001
Last Updated:	January 3, 2009
ClinicalTrials.gov Identifier:	NCT00020488 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Antimetabolites
Vitamin B Complex
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Irinotecan
Physiological Effects of Drugs
Leucovorin

Enzyme Inhibitors
Immunosuppressive Agents
Camptothecin
Pharmacologic Actions
Vitamins
Fluorouracil
Therapeutic Uses
Micronutrients
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009