A Protocol of Irinotecan for Carcinoma of the Lung

Sponsor
Susanne Arnold
Study ID
NCT01654081
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    Irinotecan 125 mg/m2 on days 1, 8, 15 and 22 of every 6- week cycle

Study Details

The goal of this trial is to demonstrate the potential clinical benefit of irinotecan chemotherapy in patients with a specific NSCLC phenotype, ISG15-positive. The use of irinotecan in subjects with ISG15-positive NSCLC will be associated with an improved rate of clinical benefit (objective response, disease stability, and time to progression) compared to historical controls that were not previously selected for ISG-15 expression.

Key Dates

Start date
Oct 31, 2013
Status verified
May 2014
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

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

Arms

  • Experimental: Irinotecan
    Irinotecan 125 mg/m2 on days 1, 8, 15 and 22 of every 6- week cycle

Primary Outcome Measure

Progression-free survival following irinotecan therapy [ Time Frame: up to five years after initiation of protocol therapy ]

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