NCT00433550 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2017-08-24

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Confirmed Tumor Response Rate (Proportion of Participants With Complete Response)

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression Free Survival

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outcome · POSTED

Duration of Response

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outcome · POSTED

Time to Treatment Failure

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria * 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 * Hemoglobin \>= 9.0 g/dL * Creatinine =\< 1.5 x UNL (if \> 1.5 x UNL, calculated creatinine clearance should be checked.; if it is \> 60 mL/min, then the patient is eligible for the study) * Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only Exclusion Criteria * 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive irinotecan hydrochloride IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine PO BID on days 2-15
intervention Names
Drug: capecitabine
Drug: irinotecan hydrochloride
Drug: oxaliplatin
label
Group 1 (6/6 UGT1A1 genotype)
type
EXPERIMENTAL
description
Patients receive irinotecan hydrochloride as in group 1. They also receive oxaliplatin and capecitabine as in group 1 but at lower doses.
intervention Names
Drug: capecitabine
Drug: irinotecan hydrochloride
Drug: oxaliplatin
label
Group 2 (6/7 UGT1A1 genotype)
type
EXPERIMENTAL
description
Patients receive irinotecan hydrochloride, oxaliplatin, and capecitabine as in group 1 but at lower doses.
intervention Names
Drug: capecitabine
Drug: irinotecan hydrochloride
Drug: oxaliplatin
label
Group 3 (7/7 UGT1A1 genotype)
type
EXPERIMENTAL

interventions

arm Group Labels
Group 1 (6/6 UGT1A1 genotype)
Group 2 (6/7 UGT1A1 genotype)
Group 3 (7/7 UGT1A1 genotype)
description
given orally
name
capecitabine
type
DRUG
arm Group Labels
Group 1 (6/6 UGT1A1 genotype)
Group 2 (6/7 UGT1A1 genotype)
Group 3 (7/7 UGT1A1 genotype)
description
given IV
name
irinotecan hydrochloride
type
DRUG
arm Group Labels
Group 1 (6/6 UGT1A1 genotype)
Group 2 (6/7 UGT1A1 genotype)
Group 3 (7/7 UGT1A1 genotype)
description
given IV
name
oxaliplatin
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 33
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Confirmed Tumor Response Rate (Proportion of Participants With Complete Response)
time Frame
36 weeks

secondary Outcomes

description
Overall survival will be defined as the time from registration to death. Patients lost to follow-up for this endpoint will be censored at the date of last contact (i.e., last known alive). The distribution of overall survival will be estimated using Kaplan-Meier methodology.
measure
Overall Survival
time Frame
Up to 2 years
description
Time to disease progression is defined as the time from registration to the earlier of documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The distribution of time to progression will be estimated using Kaplan-Meier methodology.
measure
Progression Free Survival
time Frame
Up to 2 years
description
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be analyzed using Kaplan-Meier methods.
measure
Duration of Response
time Frame
Up to 2 years
description
Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. If the patient is considered to have had a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. Time to treatment failure will be analyzed using Kaplan-Meier methods.
measure
Time to Treatment Failure
time Frame
Up to 2 years

Full study description

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.
detailed Description: PRIMARY OBJECTIVE: To assess the confirmed tumor response of the combination of oxaliplatin, irinotecan (irinotecan hydrochloride), and capecitabine in patients with advanced adenocarcinoma of the small bowel when dosed according to UGT1A1 genotype. SECONDARY OBJECTIVES: 1. To assess the toxicity of this regimen in these groups of patients. 2. To gain preliminary data on whether microsatellite instability influences outcome within this arm. 3. To gain preliminary data on whether evidence of celiac disease may affect toxicity and outcome. 4. To gain preliminary data on whether site of tumor origin (duodenal, jejunal, or ileal) affects response or survival. OUTLINE: Patients are assigned to 1 of 3 treatment groups based on UGT1A1 genotype. GROUP 1 (6/6 UGT1A1 genotype): Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine orally (PO) twice daily (BID) 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. After the completion of study treatment, patients are followed every 6 weeks for 2 years and then periodically thereafter.

Source references

references

citation
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
24114122
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice