Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer

Basic Trial Information

Objectives

Primary

1. Assess the confirmed tumor response in patients with metastatic or unresectable locally advanced adenocarcinoma of the small bowel treated with irinotecan hydrochloride, oxaliplatin, and capecitabine when dosed according to UGT1A1 genotype.

Secondary

1. Assess the toxicity of this regimen in these patients.
2. Assess, preliminarily, whether celiac disease may affect toxicity and outcome in patients treated with this regimen.
3. Assess, preliminarily, whether tumor origin (duodenal, jejunal, or ileal) affects response or survival in these patients.

Entry Criteria

Disease Characteristics:

• Histologically* or cytologically* confirmed small bowel adenocarcinoma
  • Metastatic or unresectable locally advanced disease

   [Note: *Biopsy may be of primary tumor or from a metastatic site if there is a primary small bowel tumor or currently or previously present.]

• Measurable disease
  • For patients with lesions ≥ 1 cm but < 2 cm, spiral CT scan imaging must be used for tumor assessments

• Confirmed UGT1A1 TA indel genotype of 6/6, 6/7, or 7/7

• No periampullary carcinoma or appendiceal cancer

• No known CNS metastases or carcinomatous meningitis

Prior/Concurrent Therapy:

• At least 2 weeks since prior radiotherapy
• At least 4 weeks since prior major surgery
• No prior chemotherapy for advanced small bowel cancer
  • Prior adjuvant fluorouracil/leucovorin calcium allowed provided last dose was ≥ 3 months ago
  • No prior adjuvant oxaliplatin or irinotecan hydrochloride
• No prior radiotherapy to > 25% of bone marrow
• No concurrent sorivudine, brivudine, lamivudine, or stavudine
• No concurrent sargramostim (GM-CSF) or pegfilgrastim

Patient Characteristics:

• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastasis is present)
• Bilirubin normal for patients with 6/6 genotype (< 2 times ULN for patients with 6/7 or 7/7 genotype)
• Hemoglobin ≥ 9.0 g/dL
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active or uncontrolled infection
• No other concurrent malignancy, except for nonmelanoma skin cancer
• No preexisting sensory neuropathy ≥ grade 2
• No evidence of serious intercurrent illness, including any of the following:
  • Unstable angina
  • Symptomatic congestive heart failure
  • Serious uncontrolled cardiac arrhythmia

Expected Enrollment

A total of 33 patients will be accrued for this study.

Outcomes

Confirmed tumor response (complete or partial response) after 12 courses of study therapy

Overall survival
Time to disease progression
Duration of response
Time to treatment failure
Incidence of celiac disease
Correlation of celiac disease with incidence of grade 3 or greater gastrointestinal toxicity
UGT1A7 and UGT1A9 polymorphism
Tumor location
Effect of different drug doses on response rates and toxicity

Outline

This is a prospective, multicenter study. Patients are assigned to 1 of 3 treatment groups based on UGT1A1 genotype.

• Group 1 (6/6 UGT1A1 genotype): Patients receive irinotecan hydrochloride IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 2-15.

• Group 2 (6/7 UGT1A1 genotype): Patients receive irinotecan hydrochloride as in group 1. They also receive oxaliplatin and capecitabine as in group 1 but at lower doses.

• Group 3 (7/7 UGT1A1 genotype): Patients receive irinotecan hydrochloride, oxaliplatin, and capecitabine as in group 1 but at lower doses.

In all groups, treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Blood and serum samples are collected at baseline for UGT1A1 genotyping, celiac disease testing, and research studies, including translational and pharmacologic studies.

After the completion of study treatment, patients are followed every 6 weeks for 2 years and then periodically thereafter.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Robert McWilliams, MD, Protocol chair		Ph: 507-284-8432
Benjamin Marchello, MD, Protocol co-chair		Ph: 507-538-7623
Matthew Goetz, MD, Protocol co-chair		Ph: 507-538-7623 Email: goetz.matthew@mayo.edu
Aminah Jatoi, MD, Protocol co-chair		Ph: 507-538-7623

U.S.A.
Connecticut
	Hartford
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Philip Stella, MD	Ph:  734-712-1000
Idaho
	Boise
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Clinical Trials Office - Saint Alphonsus Cancer Care Center	Ph:  208-367-7954
Iowa
	Cedar Rapids
	Cedar Rapids Oncology Associates
		Clinical Trials Office - Cedar Rapids Oncology Associates	Ph:  319-363-2690
	Mercy Regional Cancer Center at Mercy Medical Center
		Deborah Wilbur	Ph:  319-398-6011
	Clive
	Medical Oncology and Hematology Associates - West Des Moines
		Robert Behrens	Ph:  515-875-9713
	Des Moines
	CCOP - Iowa Oncology Research Association
		Robert Behrens	Ph:  515-244-7586 888-244-6061
	John Stoddard Cancer Center at Iowa Lutheran Hospital
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital	Ph:  515-241-8704
	John Stoddard Cancer Center at Iowa Methodist Medical Center
		Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center	Ph:  515-241-6727
	Medical Oncology and Hematology Associates at John Stoddard Cancer Center
		Robert Behrens	Ph:  515-282-2921
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Robert Behrens	Ph:  515-643-8740
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert Behrens	Ph:  515-643-8206 888-221-4849
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-0088
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Fort Scott
	Cancer Center of Kansas - Fort Scott
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Liberal
	Cancer Center of Kansas, PA - Liberal
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wichita
	Associates in Womens Health, PA - North Review
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Michigan
	Adrian
	Hickman Cancer Center at Bixby Medical Center
		Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center	Ph:  517-265-0116
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  734-712-1000
	Saint Joseph Mercy Cancer Center
		Philip Stella, MD	Ph:  734-712-1000
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center	Ph:  313-593-8090
	Escanaba
	Green Bay Oncology, Limited - Escanaba
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	Flint
	Genesys Hurley Cancer Institute
		Clinical Trials Office - Genesys Hurley Cancer Institute	Ph:  810-762-8057
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph:  810-762-8057
	Grosse Pointe Woods
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center	Ph:  313-343-3166
	Iron Mountain
	Dickinson County Healthcare System
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	Jackson
	Foote Memorial Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Lansing
	Sparrow Regional Cancer Center
		Clinical Trials Office - Sparrow Regional Cancer Center	Ph:  517-364-2890
	Livonia
	St. Mary Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Monroe
	Community Cancer Center of Monroe
		Rex Mowat	Ph:  734-242-7902
	Mercy Memorial Hospital - Monroe
		Rex Mowat	Ph:  734-240-8400
	Pontiac
	St. Joseph Mercy Oakland
		Philip Stella, MD	Ph:  734-712-1000
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Clinical Trials Office - Seton Cancer Institute - Saginaw	Ph:  989-776-8411
	Warren
	St. John Macomb Hospital
		Philip Stella, MD	Ph:  734-712-1000
Minnesota
	Brainerd
	St. Joseph's Medical Center
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Burnsville
	Fairview Ridges Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Coon Rapids
	Mercy and Unity Cancer Center at Mercy Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Duluth
	CCOP - Duluth
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Duluth Clinic Cancer Center - Duluth
		Clinical Trials Office - Duluth Clinic Cancer Center - Duluth	Ph:  218-786-3308
	Miller - Dwan Medical Center
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Edina
	Fairview Southdale Hospital
		Clinical Trials Office - Fairview Southdale Hospital	Ph:  612-625-3650
	Fridley
	Mercy and Unity Cancer Center at Unity Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Hutchinson
	Hutchinson Area Health Care
		Patrick Flynn, MD	Ph:  612-863-8585
	Maplewood
	HealthEast Cancer Care at St. John's Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Minnesota Oncology - Maplewood
		Patrick Flynn, MD	Ph:  612-863-8585
	Minneapolis
	Hennepin County Medical Center - Minneapolis
		Clinical Trials Office - Hennepin County Medical Center - Minneapolis	Ph:  612-873-5911
	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
		Clinical Trials Office - Virginia Piper Cancer Institute	Ph:  612-863-5654
	Robbinsdale
	Humphrey Cancer Center at North Memorial Outpatient Center
		Clinical Trials Office - Humphrey Cancer Center at North Memorial Outpatient Center	Ph:  763-520-1893
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  612-863-8585
	Park Nicollet Cancer Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Saint Paul
	United Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Shakopee
	St. Francis Cancer Center at St. Francis Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
	St. Paul
	Regions Hospital Cancer Care Center
		Clinical Trials Office - Regions Hospital Cancer Care Center	Ph:  651-254-1517
	Stillwater
	Lakeview Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Waconia
	Ridgeview Medical Center
		Patrick Flynn, MD	Ph:  612-863-8585
	Willmar
	Willmar Cancer Center at Rice Memorial Hospital
		Patrick Flynn, MD	Ph:  612-863-8585
	Woodbury
	Minnesota Oncology - Woodbury
		Patrick Flynn, MD	Ph:  612-863-8585
Montana
	Billings
	Billings Clinic - Downtown
		Clinical Trials Office - Billings Clinic - Downtown	Ph:  800-996-2663
			Email: research@billingsclinic.org
	CCOP - Montana Cancer Consortium
		Benjamin Marchello, MD	Ph:  406-238-6290
	Hematology-Oncology Centers of the Northern Rockies - Billings
		Benjamin Marchello, MD	Ph:  406-238-6290
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Butte
	St. James Healthcare Cancer Care
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-238-6290
	Sletten Cancer Institute at Benefis Healthcare
		Benjamin Marchello, MD	Ph:  406-238-6290
	Havre
	Northern Montana Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Helena
	St. Peter's Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell
	Glacier Oncology, PLLC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Medical Oncology at KRMC
		Benjamin Marchello, MD	Ph:  406-238-6290
	Kalispell Regional Medical Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Missoula
	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
		Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Ph:  406-329-7029
	Montana Cancer Specialists at Montana Cancer Center
		Clinical Trials Office - Montana Cancer Specialists at Montana Cancer Center	Ph:  406-238-6962
North Dakota
	Bismarck
	Bismarck Cancer Center
		Edward Wos, DO	Ph:  701-323-5741
	Medcenter One Hospital Cancer Care Center
		Edward Wos, DO	Ph:  701-323-5741
	Mid Dakota Clinic, PC
		Clinical Trials Office - Mid Dakota Clinic, PC	Ph:  701-530-6950
	St. Alexius Medical Center Cancer Center
		Clinical Trials Office - St. Alexius Medical Center Cancer Center	Ph:  701-530-6950
	Grand Forks
	Altru Cancer Center at Altru Hospital
		Clinical Trails Office - Altru Cancer Center at Altru Hospital	Ph:  701-780-6520
Ohio
	Bowling Green
	Wood County Oncology Center
		Rex Mowat	Ph:  419-352-9498
	Elyria
	Community Cancer Center
		Rex Mowat	Ph:  440-324-0400
	Hematology Oncology Center
		Rex Mowat	Ph:  440-324-0401
	Lima
	Lima Memorial Hospital
		Rex Mowat	Ph:  419-228-3335
	Maumee
	Northwest Ohio Oncology Center
		Rex Mowat	Ph:  419-891-5600
		Rex Mowat	Ph:  419-891-5600
	Norwalk
	Fisher-Titus Medical Center
		Rex Mowat	Ph:  419-668-8101 800-589-3862
	Oregon
	St. Charles Mercy Hospital
		Rex Mowat	Ph:  419-696-7200
	Toledo Clinic - Oregon
		Rex Mowat	Ph:  419-691-4235
	Sylvania
	Flower Hospital Cancer Center
		Clinical Trials Office - Flower Hospital Cancer Center	Ph:  419-824-1842
	Tiffin
	Mercy Hospital of Tiffin
		Rex Mowat	Ph:  419-447-3130
	Toledo
	CCOP - Toledo Community Hospital
		Rex Mowat	Ph:  419-843-6147
	Medical University of Ohio Cancer Center
		Clinical Trials Office - Medical University of Ohio Cancer Center	Ph:  419-383-6583
	St. Anne Mercy Hospital
		Rex Mowat	Ph:  419-407-2663
	St. Vincent Mercy Medical Center
		Rex Mowat	Ph:  419-251-4515
	Toledo Clinic, Incorporated - Main Clinic
		Rex Mowat	Ph:  419-479-5605
	Toledo Hospital
		Clinical Trials Office - Toledo Hospital	Ph:  419-824-1842
	Wauseon
	Fulton County Health Center
		Clinical Trials Office - Fulton County Health Center	Ph:  419-330-2708
South Dakota
	Rapid City
	Rapid City Regional Hospital
		Richard Tenglin	Ph:  605-719-2360
Virginia
	Fredericksburg
	Fredericksburg Oncology, Incorporated
		Rex Mowat	Ph:  540-368-0500
Wisconsin
	Green Bay
	Green Bay Oncology, Limited at St. Mary's Hospital
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	St. Mary's Hospital Medical Center - Green Bay
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Manitowoc
	Holy Family Memorial Medical Center Cancer Care Center
		Clinical Trials Office - Holy Family Memorial Medical Center Cancer Care Center	Ph:  920-320-2749
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	Oconto Falls
	Green Bay Oncology, Limited - Oconto Falls
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	Sheboygan
	St. Nicholas Hospital
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
	Sturgeon Bay
	Green Bay Oncology, Limited - Sturgeon Bay
		Anthony Jaslowski, MD, FACP	Ph:  920-884-3135
Wyoming
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290

Registry Information
Official Title		A Phase II Trial of Pharmacogenetic-Based Dosing of Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy for Advanced Small Bowel Adenocarcinoma
Trial Start Date		2007-05-11
Trial Completion Date		2008-09-17 (estimated)
Registered in ClinicalTrials.gov		NCT00433550
Date Submitted to PDQ		2006-12-18
Information Last Verified		2012-05-17
NCI Grant/Contract Number		CA25224

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