Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
A Phase II Trial of Pharmacogenetic-Based Dosing of Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy for Advanced Small Bowel Adenocarcinoma
3 other identifiers
interventional
33
1 country
115
Brief Summary
This phase II trial studies how well giving irinotecan hydrochloride together with oxaliplatin and capecitabine works as first-line therapy in treating patients with metastatic or unresectable locally advanced small bowel cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2007
Longer than P75 for phase_2
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2007
CompletedFirst Posted
Study publicly available on registry
February 12, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
August 24, 2017
CompletedAugust 24, 2017
July 1, 2017
7.6 years
February 8, 2007
February 15, 2017
July 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Confirmed Tumor Response Rate (Proportion of Participants With Complete Response)
Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.
36 weeks
Secondary Outcomes (4)
Overall Survival
Up to 2 years
Progression Free Survival
Up to 2 years
Duration of Response
Up to 2 years
Time to Treatment Failure
Up to 2 years
Study Arms (3)
Group 1 (6/6 UGT1A1 genotype)
EXPERIMENTALPatients receive irinotecan hydrochloride IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine PO BID on days 2-15
Group 2 (6/7 UGT1A1 genotype)
EXPERIMENTALPatients 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)
EXPERIMENTALPatients receive irinotecan hydrochloride, oxaliplatin, and capecitabine as in group 1 but at lower doses.
Interventions
given orally
given IV
given IV
Eligibility Criteria
You may qualify if:
- Confirmation UDP glucuronosyltransferase 1 family, polypeptide A complex locus (UGT1A1) TA indel genotype of 6/6, 6/7, or 7/7 after pre-registration but prior to registration
- Patient willingness to provide a serum sample for analysis for celiac disease (tissue transglutaminase antibodies)
- Small bowel adenocarcinoma, either metastatic or locally advanced and not surgically resectable; NOTE: periampullary carcinoma and appendiceal cancer are not eligible
- Histologic or cytologic confirmation of adenocarcinoma consistent with small bowel origin; biopsy can be of primary tumor or can be from a metastatic site if there is a primary small bowel tumor currently or previously present
- Measurable disease; for patients with lesions \>= 1 cm but \< 2 cm, spiral computed tomography (CT) scan imaging must be used for tumor assessments
- Life expectancy \>= 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- \>= 4 weeks since prior major surgery to time of registration
- \>= 2 weeks from completion of any radiation treatment
- Absolute neutrophil count (ANC) \>= 1,500/mm\^3
- Platelets \>= 100,000/mm\^3
- Serum glutamic oxaloacetic transaminase (SGOT) =\< 5 x upper normal limit (UNL); =\< 2.5 x UNL if no liver metastases
- Total bilirubin:
- For 6/6 patients: =\< upper limit of normal (ULN)
- For 6/7 or 7/7 patients: =\< 2.0 x ULN
- +3 more criteria
You may not qualify if:
- Prior chemotherapy regimen for advanced small bowel cancer (prior adjuvant chemotherapy with fluorouracil (5FU)/leucovorin is permitted if last dose was administered \>= 3 months prior to registration); prior oxaliplatin or irinotecan use as adjuvant therapy is not permitted
- Prior radiotherapy to \> 25% of bone marrow
- Active or uncontrolled infection
- Evidence of serious intercurrent illness (e.g., unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)
- Pregnant women; women of child-bearing potential and men must agree to use adequate contraception (diaphragm, birth control pills, injections, foams, intrauterine device \[IUD\], or abstinence, etc.) for the duration of study participation; if a woman becomes pregnant or suspects that she is pregnant while participating in this study, she should inform her treating physician immediately and all study treatment discontinued
- Nursing women; breast-feeding should be discontinued when the mother is treated with these agents
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Current evidence of other malignancy besides small bowel adenocarcinoma, with exception of non-melanoma skin cancer
- Known central nervous system metastases or carcinomatous meningitis
- Preexisting sensory neuropathy \>= grade 2 from any cause interfering with function
- Concurrent therapy with sorivudine, brivudine, lamivudine, or stavudine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alliance for Clinical Trials in Oncologylead
- National Cancer Institute (NCI)collaborator
- Pfizercollaborator
- Sanoficollaborator
Study Sites (115)
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51102, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801, United States
Foote Memorial Hospital
Jackson, Michigan, 49201, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Community Cancer Center of Monroe
Monroe, Michigan, 48162, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, 48162, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601, United States
St. John Macomb Hospital
Warren, Michigan, 48093, United States
St. Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health - Duluth Clinic
Duluth, Minnesota, 55805-1983, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109, United States
Minnesota Oncology - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology - Woodbury
Woodbury, Minnesota, 55125, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59102, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
St. James Healthcare Cancer Care
Butte, Montana, 59701, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
St. Peter's Hospital
Helena, Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, United States
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501, United States
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, 58502, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, 58201, United States
Wood County Oncology Center
Bowling Green, Ohio, 43402, United States
Community Cancer Center
Elyria, Ohio, 44035, United States
Hematology Oncology Center
Elyria, Ohio, 44035, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Northwest Ohio Oncology Center
Maumee, Ohio, 43537-1839, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon, Ohio, 43616, United States
Flower Hospital Cancer Center
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614, United States
St. Anne Mercy Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, 43623, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, 54221-1450, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
St. Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Related Publications (1)
Goetz MP, McKean HA, Reid JM, Mandrekar SJ, Tan AD, Kuffel MA, Safgren SL, McGovern RM, Goldberg RM, Grothey AA, McWilliams R, Erlichman C, Ames MM. UGT1A1 genotype-guided phase I study of irinotecan, oxaliplatin, and capecitabine. Invest New Drugs. 2013 Dec;31(6):1559-67. doi: 10.1007/s10637-013-0034-9. Epub 2013 Oct 10.
PMID: 24114122DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert R. McWilliams, M.D.
- Organization
- Mayo Clinic
Study Officials
- STUDY CHAIR
Robert McWilliams, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2007
First Posted
February 12, 2007
Study Start
May 1, 2007
Primary Completion
December 1, 2014
Study Completion
May 1, 2016
Last Updated
August 24, 2017
Results First Posted
August 24, 2017
Record last verified: 2017-07