Oxaliplatin and Irinotecan in Recurrent or Metastatic Esophageal and Gastroesophageal (GE) Junction Carcinoma

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT00256269
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
    40 mg/m2 IV over 60 minutes Every 21 days
  • Irinotecan — DRUG
    60 mg/m2 IV over 60 minutes, immediately following oxaliplatin Every 21 days

Study Details

The combination of cisplatin and irinotecan has significant anti-tumor activity in esophageal cancer. Oxaliplatin has been shown to have activity in combination with 5-Fluorouracil (5FU) and radiation in treatment of locally advanced esophageal cancer. Oxaliplatin also has better side effects profile than cisplatin and may be able to overcome tumors that have developed cisplatin resistance. The standard treatment of locally advanced esophageal cancer has been cisplatin, 5FU and radiation followed by possible esophagectomy. However, a large portion of these patients will relapse and the tumor may develop resistance to cisplatin and/or the cumulative toxicity from previous treatment forbids the use of cisplatin again. Weekly combination of oxaliplatin and irinotecan has been shown to be active and well tolerated in elderly population with refractory colorectal cancer. Therefore, we propose this phase II trial of a weekly oxaliplatin and irinotecan to test the effectiveness and the tolerability of this regimen in metastatic and/or recurrent esophageal cancer.

Key Dates

Start date
Jun 30, 2005
Status verified
Jan 2018
Primary completion
Feb 7, 2007
Completion
Feb 7, 2007

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Oxaliplatin plus Irinotecan
    Drug: Oxaliplatin-40 mg/m2 IV over 60 minutes Every 21 days. Drug: Irinotecan-60 mg/m2 IV over 60 minutes, immediately following oxaliplatin Every 21 days.

Primary Outcome Measure

To assess the overall response rate [ Time Frame: 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-

Find similar trials in Orange, CA

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
Chao Family Comprehensive Cancer Center· Orange, CA

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