NCT01654081
Withdrawn
Phase 2
A Non-randomized Phase II Protocol of Irinotecan for Patients With Previously Treated, Advanced ISG15-positive Non-small Cell Carcinoma of the Lung
Overview
- Phase
- Phase 2
- Intervention
- Irinotecan
- Conditions
- Lung Cancer
- Sponsor
- Susanne Arnold
- Primary Endpoint
- Progression-free survival following irinotecan therapy
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Susanne Arnold
Principal Investigator
University of Kentucky
Eligibility Criteria
Inclusion Criteria
- •Subjects must be 18 years of age or greater with histologically or cytologically confirmed non-small cell lung cancer that is advanced and cannot be treated adequately by radiotherapy or surgery; or metastatic or recurrent disease after at least one prior chemotherapy regimen
- •Prior invasive malignancies are allowed, provided at least five years has elapsed since the completion of therapy and enrollment on this protocol.
- •All participants must have received at least one prior chemotherapy regimen for metastatic NSCLC; prior adjuvant or neoadjuvant chemotherapy for NSCLC will also be allowed, but will NOT be counted toward the number of regimens for metastatic disease unless patients develop evidence of metastatic disease within six months of the initiation of the adjuvant chemotherapy, indicating resistance to platinum-based therapy. There is no limit on the number of prior regimens allowed, provided the patient meets all other eligibility criteria. Patients who may best benefit from the application of specific targeted therapies (i.e., erlotinib for EGFR exon 19 or 21 activating mutations, or crizotinib for EML4-ALK translocations) will be eligible for this protocol only after documented progression through such targeted therapy AND a platinum-based doublet regimen
- •All participants must have the appropriate phenotype on pretreatment screening of tumor tissue or sputa, consisting of ISG15-positive cells by immunohistochemistry (staining score of 4-12, as defined in section 4.2), performed by the UK Department of Pathology, and must agree to have their tissues evaluated for ISG15 expression (a separate informed consent will be requested). Potential participants who have no available tissue for assessment will be offered sputum assessment or tissue biopsy if it can be performed safely, potential disease sites can be safely approached, and only if it is the opinion or their attending physician that participation in this protocol represents their best treatment option at this time. Subjects with assessable material will not be required to undergo a separate biopsy solely for participation in this protocol.
- •Subjects must have the following baseline laboratory values (bone marrow, renal, hepatic):
- •Adequate bone marrow function:
- •Absolute neutrophil count \>1000/μL
- •Platelet count \>100'000/μL
- •Serum creatinine \< 2.0 mg/dL
- •Bilirubin \<1.5x normal
Exclusion Criteria
- •Prior therapy with irinotecan, topotecan, or other camptothecin analog
- •Patients whose tumor harbors an EGFR exon 19 or 21 mutation who has not yet received prior therapy with an EGFR-specific tyrosine kinase inhibitor such as erlotinib or gefitinib
- •Patients whose tumor harbors an EML4/ALK translocation and who has not yet received crizotinib
- •Pregnant or lactating females
- •Myocardial infarction or ischemia, or active cerebrovascular disease, within the 6 months before Cycle 1' Day 1
- •Uncontrolled clinically significant dysrhythmia
- •Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
- •Uncontrolled metastatic disease of the central nervous system (previously treated, stable disease is allowable on this protocol)
- •Radiotherapy within the 2 weeks before registration
- •Surgery within the 2 weeks before registration
Arms & Interventions
Irinotecan
Irinotecan 125 mg/m2 on days 1, 8, 15 and 22 of every 6- week cycle
Intervention: Irinotecan
Outcomes
Primary Outcomes
Progression-free survival following irinotecan therapy
Time Frame: up to five years after initiation of protocol therapy
Progression-free survival following irinotecan therapy
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