Paclitaxel and Irinotecan in Advanced Gastric Cancer

Sponsor
Seoul National University Hospital
Study ID
NCT01136031
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel and irinotecan — DRUG
    In phase I part, Level Paclitaxel (mg/m²) Irinotecan (mg/m²) 1. 100 100 2. 100 120 3. 135 120 4. 135 160 every 3 week

Study Details

* Usually the combination of fluoropyrimidine with platinum is used as a first line chemotherapy (for example, 5-FU+cisplatin, capecitabine+cisplatin, S-1+ cisplatin, 5-FU+oxaliplatin) in advanced gastric cancer. * After failure with this combination, taxane-based regimen or irinotecan-based regimen is usually used. But, as a second-line regimen, the combination of topoisomerase inhibitor with taxane has not been fully evaluated until now. * So we designed this phase I/II study to evaluate the efficacy and toxicity of second-line chemotherapy with paclitaxel and irinotecan in fluoropyrimidine and platinum-pretreated advanced gastric cancer.

Key Dates

Start date
Jan 31, 2008
Status verified
May 2010
Primary completion
Jun 30, 2011
Completion
Aug 31, 2011

Study Design

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

Arms

  • Experimental: Paclitaxel and irinotecan

Primary Outcome Measure

Dose-limiting toxicity (phase I part) [ Time Frame: during first cycle (first 3 week) ]

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