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

Conditions

• Recurrent Small Intestine Cancer
• Small Intestine Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• capecitabine — DRUG
  given orally
• irinotecan hydrochloride — DRUG
  given IV
• oxaliplatin — DRUG
  given IV

Study Details

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.

Key Dates

Start date

May 31, 2007

Status verified

Jul 2017

Primary completion

Dec 31, 2014

Completion

May 31, 2016

Study Design

Enrollment

33 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1 (6/6 UGT1A1 genotype)
  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
• Experimental: 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.
• Experimental: Group 3 (7/7 UGT1A1 genotype)
  Patients receive irinotecan hydrochloride, oxaliplatin, and capecitabine as in group 1 but at lower doses.

Primary Outcome Measure

Confirmed Tumor Response Rate (Proportion of Participants With Complete Response) [ Time Frame: 36 weeks ]

Locations (115)

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