|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 November 2012 |
|
Main ID: |
NCT00433550 |
|
Date of registration:
|
08/02/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
|
|
Scientific title:
|
A Phase II Trial of Pharmacogenetic-Based Dosing of Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy for Advanced Small Bowel Adenocarcinoma |
|
Date of first enrolment:
|
May 2007 |
|
Target sample size:
|
33 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00433550 |
|
Study type:
|
Interventional |
|
Study design:
|
Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Benjamin T. Marchello, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CCOP - Montana Cancer Consortium |
|
|
Name:
|
Aminah Jatoi, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mayo Clinic |
|
|
Name:
|
Matthew P. Goetz, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mayo Clinic |
|
|
Name:
|
Robert McWilliams, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mayo Clinic |
| | |
|
Key inclusion & exclusion 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
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
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Small Intestine Cancer
|
|
Intervention(s)
|
|
Drug: capecitabine
|
|
Drug: irinotecan hydrochloride
|
|
Drug: oxaliplatin
|
|
Primary Outcome(s)
|
|
Confirmed tumor response (complete or partial response) after 12 courses of study therapy
[Time Frame: No]
|
|
Secondary Outcome(s)
|
|
Correlation of celiac disease with incidence of grade 3 or greater gastrointestinal toxicity
[Time Frame: Yes]
|
|
Duration of response
[Time Frame: No]
|
|
Effect of different drug doses on response rates and toxicity
[Time Frame: Yes]
|
|
Incidence of celiac disease
[Time Frame: No]
|
|
Overall survival
[Time Frame: No]
|
|
Time to disease progression
[Time Frame: No]
|
|
Time to treatment failure
[Time Frame: No]
|
|
Tumor location
[Time Frame: No]
|
|
UGT1A7 and UGT1A9 polymorphism
[Time Frame: No]
|
|
Secondary ID(s)
|
|
CDR0000528263
|
|
NCCTG-N0543
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|