Irinotecan and Cisplatin for High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00353015
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Neuroendocrine
  • Gastrointestinal Cancer

Eligibility Criteria

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

Interventions

  • Cisplatin — DRUG
    Cisplatin 25 mg/m2 IV days 1, 8 of a 21-day cycle
  • Irinotecan — DRUG
    Irinotecan 65 mg/m2 IV days 1, 8 of a 21-day cycle

Study Details

Primary Objective: 1\. Assess the clinical activity defined by response rate of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract. Secondary Objective: 1\. To assess the safety profile of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract.

Key Dates

Start date
Mar 31, 2003
Status verified
Aug 2012
Primary completion
Dec 31, 2007
Completion
Jul 31, 2009

Study Design

Enrollment
21 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan plus Cisplatin
    Irinotecan 65 mg/m2 and Cisplatin 25 mg/m2 intravenous (IV) days 1, 8 of a 21-day cycle

Primary Outcome Measure

Participant Response Rate of Irinotecan and Cisplatin [ Time Frame: Every 3 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
U.T. M.D. Anderson Cancer CenterHoustonTexas77030-

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