Irinotecan in Treating Aging Patients With Solid Tumors

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00026195

Collaborator

National Cancer Institute (NCI) (NIH)

140

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Aging may affect the way these drugs work.

PURPOSE: Phase I trial to determine the relationship between aging and the effectiveness of irinotecan in treating patients who have solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: irinotecan hydrochloride	Phase 1

Detailed Description

OBJECTIVES:

Determine whether there is a relationship between the pharmacokinetic characteristics of irinotecan and aging in patients with non-hematologic malignancies.
Determine whether there is a relationship between the toxic effects of this drug and aging in these patients.
Determine whether the relationship between genotype (UGT1A1, CYP3A, and other relevant genes) and phenotype (pharmacokinetics, toxicity) is affected by aging in these patients treated with this drug.
Analyze data collected on the co-morbid conditions and concurrent medications in these patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to age (18 to 55 vs 70 and over).

Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 140 patients (70 per stratum) will be accrued for this study within 3.5 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Pharmacology In The Elderly: Prospective Evaluation Of The Pharmacokinetics, Pharmacogenetics And Pharmacodynamics Of CPT-11 And Aging

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: irinotecan Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for survival.	Drug: irinotecan hydrochloride

Arm

Intervention/Treatment

Experimental: irinotecan

Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for survival.

Drug: irinotecan hydrochloride

Outcome Measures

Primary Outcome Measures

overall survival [Up to 10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed non-hematologic malignancy
Brain metastases or primary brain tumors are eligible provided patient is not receiving steroids or antiepileptic medications

PATIENT CHARACTERISTICS:

Age:

18 to 55 or 70 and over

Performance status:

CTC 0-2

Life expectancy:

Not specified

Hematopoietic:

Granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than upper limit of normal (ULN)
SGOT no greater than ULN

Renal:

Creatinine no greater than ULN

Other:

Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea)
No more than 1 prior chemotherapy regimen for metastatic disease (no limit if administered in the adjuvant setting)
No prior camptothecin

Endocrine therapy:

See Disease Characteristics

Radiotherapy:

At least 4 weeks since prior radiotherapy
No concurrent radiotherapy, including for palliation

Surgery:

At least 4 weeks since prior major surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rebecca and John Moores UCSD Cancer Center	La Jolla	California	United States	92093-0658
2	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
3	Veterans Affairs Medical Center - San Francisco	San Francisco	California	United States	94121
4	UCSF Comprehensive Cancer Center	San Francisco	California	United States	94143-0128
5	CCOP - Christiana Care Health Services	Wilmington	Delaware	United States	19899
6	Lombardi Cancer Center	Washington	District of Columbia	United States	20007
7	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
8	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
9	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612-7323
10	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
11	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
12	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
13	Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242-1009
14	Marlene and Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
15	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
16	University of Massachusetts Memorial Medical Center - University Campus	Worcester	Massachusetts	United States	01655
17	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55417
18	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
19	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri	United States	65201
20	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri	United States	65203
21	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
22	Missouri Baptist Cancer Center	Saint Louis	Missouri	United States	63131
23	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-7680
24	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
25	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756-0002
26	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
27	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
28	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
29	North Shore University Hospital	Manhasset	New York	United States	11030
30	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
31	Weill Medical College of Cornell University	New York	New York	United States	10021
32	Mount Sinai Medical Center, NY	New York	New York	United States	10029
33	State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
34	Veterans Affairs Medical Center - Syracuse	Syracuse	New York	United States	13210
35	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York	United States	13217
36	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
37	Veterans Affairs Medical Center - Durham	Durham	North Carolina	United States	27705
38	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
39	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
40	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
41	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
42	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States	15224
43	Lifespan: The Miriam Hospital	Providence	Rhode Island	United States	02906
44	Green Mountain Oncology Group	Bennington	Vermont	United States	05201
45	Vermont Cancer Center	Burlington	Vermont	United States	05401-3498
46	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont	United States	05009
47	MBCCOP - Massey Cancer Center	Richmond	Virginia	United States	23298-0037

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Investigators

Study Chair: Stuart M. Lichtman, MD, Don Monti Comprehensive Cancer Center at North Shore University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT00026195

Other Study ID Numbers:

CALGB-60001
U10CA031946
CLB-60001
CDR0000068995

First Posted:

Jan 27, 2003

Last Update Posted:

Jul 6, 2016

Last Verified:

Jul 1, 2016

Keywords provided by Alliance for Clinical Trials in Oncology

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Irinotecan

Study Results

No Results Posted as of Jul 6, 2016