A Phase 2 study comparing sequential satraplatin and erlotinib to single-agent erlotinib in patients >/= 70 years of age with unresectable stage 3 or 4 non-small cell lung cancer as 1st -line therapy

• Conditions: Patients of at least 70 Years of Age with unresectable Stage 3 or 4 Non-Small Cell Lung Cancer. For further explanation see Inclusion (E.3) / Exclusion Criteria (E.4).

• Registration Number: EUCTR2006-001973-10-NL
• Lead Sponsor: GPC Biotech AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Histologically 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/uL
- Platelets > 100,000/uL
- 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 upper limit of normal (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.
• Life expectancy of at least 3 months.
• Patients with both measurable and non-measurable disease (as per Response Criteria in Solid Tumors (RECIST)) may be enrolled.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified