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).
Conditions
Interventions
Product Name: Satraplatin
Product Code: JM-216
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Satraplatin
CAS Number: 129580-63-8
Current Sponsor code: Satraplatin
Other descriptive name: JM-
Sponsors
GPC Biotech AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare Progression-Free Survival (PFS) in patients of at least 70 years of age, PS 0-1, with advanced or metastatic NSCLC in patients treated with a first-line regimen of either sequential satraplatin and erlotinib or continuous single-agent erlotinib.;Secondary Objective: • To assess Overall Survival in patients of at least 70 years of age, PS 0-1, with advanced or metastatic NSCLC in patients treated with a first-line regimen of either sequential satraplatin and erlotinib or continuous single-agent erlotinib. • To compare response rates. • To compare the toxicity profiles between patients treated with satraplatin and erlotinib and single-agent erlotinib. ;Primary end point(s): Progression Free Survival: Defined as the time from randomization until verification of progressive disease (as per RECIST) or death. Subjects who discontinue therapy without disease progression will be followed for evaluation of progressive disease every two months during the first year, every three months during the second year, and every six months thereafter until death. | — |
Countries
Italy, Netherlands
Outcome results
None listed