Status:
COMPLETED
A Study Comparing Sequential Satraplatin & Erlotinib to Erlotinib in Unresectable Stage 3/4 Non-small-cell Lung Cancer (NSCLC)
Lead Sponsor:
Agennix
Conditions:
Lung Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
Patients ≥ 70 years of age with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) frequently do not receive systemic cytotoxic chemotherapy due to concerns regarding their...
Detailed Description
Erlotinib as a single-agent is currently approved for the treatment of patients with NSCLC whose disease has progressed following one prior course of chemotherapy and is currently being evaluated in N...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, or large cell carcinoma). Cytologic specimens obtained by brushings, washings or needle biopsy with aspiration are acceptable. Mixed tumors with small cell anaplastic elements are not eligible.
- Patients who have unresectable stage III or stage IV disease are eligible. Patients with stage III disease should be ineligible for combined modality therapy (i.e. pleural effusions, pericardial effusions, etc.). Patients with earlier stage NSCLC that has recurred after prior surgery are eligible.
- Age ≥ 70 years old.
- ECOG performance status 0-1
- Prior treatment with systemic therapy is allowed provided the following criteria are met:
- No EGFR targeted therapy (TKI or antibody)
- No prior platinum agent.
- Neoadjuvant, adjuvant, or part of a combined modality regimen (i.e., not for metastatic disease)
- Completion \> 6 months prior to enrollment onto this study.
- Patients who have had previous radiation therapy (RT) as definitive therapy for locally NSCLC are eligible only if the following criteria are met:
- Site of tumor recurrence is outside of the original RT port unless there is incontrovertible evidence of disease progression within the portal
- All side effects from RT must have resolved prior to enrollment.
- Completion of RT ≥ 4 weeks prior to enrollment.
- Previous radiation must have treated \< 30% of active bone marrow.
- Patients who have undergone thoracotomy must have fully recovered from surgery and cannot start treatment until at least three weeks after their operative procedure.
- Adequate hematological function as noted by:
- Absolute neutrophil count (ANC) \> 1,500/ L
- Platelets \> 100,000/ L
- Hemoglobin \> 10 g/dl. Patients may be transfused or receive erythropoietin to maintain or exceed this level.
- Adequate hepatic and renal function as noted by:
- Bilirubin \< 1.5 x ULN
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \< 2.5 x ULN.
- Serum creatinine ≤ 1.5mg/dL or calculated (or measured) glomerular filtration rate ≥ (GFR)50 ml/min.
- Patients with both measurable and non-measurable disease (as per Response Criteria in Solid Tumors (RECIST)) may be enrolled.
Exclusion
- Concurrent invasive malignancy requiring ongoing therapy.
- Metastatic brain or meningeal tumors, unless the patient is \> 1 month from definitive therapy, is clinically stable with respect to the tumor at the time of study entry, is not receiving steroid therapy or taper, and is not receiving anti-convulsant medications (that were started for the brain metastases).
- Previous treatment with either platinum-based chemotherapy agents or prior EGFR targeting agents.
- Peripheral neuropathy \> grade 1.
- Hearing loss or tinnitus \> grade 2
- Obstructive pulmonary disease or symptoms \> grade 3.
- A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous six months, or symptomatic uncontrolled cardiac arrhythmias.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00370383
Start Date
July 1 2006
End Date
March 1 2009
Last Update
August 7 2012
Active Locations (16)
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1
Pacific Cancer Medical Center
Anaheim, California, United States, 92801
2
Scripps Clinic
La Jolla, California, United States, 92037
3
Kenmar Research Institute
Los Angeles, California, United States, 90057
4
Memorial Cancer Institute
Hollywood, Florida, United States, 33021