Elderly Patients with Advanced Non-Small-Cell Lung Cancer MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: CARBOPLATINO TEVA*1FL 600MG/60
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NA
Current Sponsor code: carboplatino
Other descriptive name: NA
Concentratio
Sponsors
AZIENDA OSPEDALIERA S. LUIGI GONZAGA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed NSCLC of adenocarcinoma, squamous cell carcinoma, large cell [53][68] carcinoma, or NSCLC not otherwise specified (NOS). For the purposes of this trial all patients that are not categorically called as squamous cell carcinoma will be referred to as non-squamous NSCLC. Patients with suspected NSCLC may enroll prior to the diagnostic biopsy in order to obtain both the diagnostic and molecular analysis-required specimen during the same procedure. 4.1.2 Willing to undergo a biopsy to enable precise histologic determination and customization of chemotherapy if necessary 4.1.3 Stage IV NSCLC by the AJCC Staging Manual 7th edition (2010) 4.1.4 Measurable or evaluable disease by RECIST 1.1[53][68] 4.1.5 Age ? 70 years 4.1.6 Performance Status 0 or 1 (by ECOG criteria) 4.1.7 Adequate bone marrow function as evidenced by the following (assessed within 21 days of study registration ): Absolute neutrophil count > 1,500/mm3 Platelet count ? 100,000/mm3 Hemoglobin > 9.0 gm/dL 4.1.8 Normal prothrombin time (PT) and activated prothrombin time with thromboplastin and kaolin (APTT) 4.1.9 Serum creatinine ? 1.5 x UNL (assessed within 21 days of study registration) 4.1.10 Adequate liver function as evidenced by the following (assessed within 21 days of study registration): Total bilirubin must be within normal limits AST (SGOT) and ALT (SGPT) ? 2.5 x UNL Alkaline Phosphatase ? 4 x UNL 4.1.11 Serum calcium ? 1.1 x UNL 4.1.12 Signed informed consent document (ICD) 4.1.13 Men with partners in the childbearing age group must use effective contraception while on treatment and for 6 months thereafter. 4.1.14 Previous surgery for NSCLC (more than 30 days before study registration) is allowed but 4.1.3 and 4.1.4 must be present 4.1.15 Previous radiotherapy is allowed if: (i) The time between completion of RT and initiation of study treatment is at least 7 days, (ii) The patient has fully recovered from all toxic effects, and (iii) At least one target lesion or evaluable disease is outside the radiation field. 4.1.16 Previous chemotherapy is allowed if the last dose was administered equal to or greater than 12 months ago. This chemotherapy must have been given in an adjuvant or neoadjuvant mode prior to or after a curative intent surgical resection for a NSCLC. Patient should be previously untreated for metastatic disease. 4.1.17 Patients with stable brain metastases will be allowed to enroll. At the time of screening, a CT scan or MRI of the brain is only required if clinically indicated. Stable brain metastasis is defined as no progression of brain metastases 14 days after conclusion of definitive treatment as documented by a CT scan or MRI of the brain. Are the trial subjects under 18? no Number of subjects for this age range: 0 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 453
Exclusion criteria
Exclusion criteria: 4.2.1 Prior systemic chemotherapy or immunotherapy for advanced NSCLC. 4.2.2 Prior malignancies, except: Cured non-melanoma skin cancer, Curatively treated in situ carcinoma of the cervix, or Any other curatively treated malignancy with no evidence of disease recurrence for at least 2 years. 4.2.3 Presence of uncontrolled brain or leptomeningeal metastases. 4.2.4 Peripheral neuropathy or hearing loss of neural origin equal to or greater than grade 2 by CTCAE v4.0 except if due to trauma 4.2.5 Other serious illness or medical condition, including but not limited to: Congestive heart failure; Myocardial infarction within 6 months; Significant neurologic or psychiatric disorders that would impact study participation as judged by the treating physician or study chair; Infection requiring I.V. antibiotics; Tuberculosis with ongoing therapy at study entry, Superior vena cava syndrome, except if controlled with radiation (see 4.1.15); Active peptic ulcer disease; Unstable diabetes mellitus; Any contraindication to high dose corticosteroid therapy such as herpes simplex, herpes zoster, hepatitis, or other disease. 4.2.6 Hypercalcemia requiring therapeutic intervention (see 4.1.11). 4.2.7 Clinically significant ascites and/or pericardial effusion. 4.2.8 Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. 4.2.9 Concurrent treatment with other investigational drugs. 4.2.10 Patients known to harbor sensitizing EGFR mutations in exons 18, 19 and 21. Patients with resistance mutation in exon 20 will be allowed to enroll i.e. T790M and D770. The rare patient who has both a resistance mutation and a sensitizing mutation at the diagnoses will be excluded in the protocol. 4.2.11 Patients whose tissue submission is not of adequate size to perform molecular testing will be excluded. Please see section 5.3.2 for details regarding adequate tissue samples sizes. Sites will be notified if there is insufficient tissue to conduct the molecular analysis. 4.2.12 Patients known to have translocations of ALK will also be excluded; however, testing for ALK translocation prior to study entry is not mandated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint is OS (determined from the date of randomization).;Secondary Objective: a) PFS at 6 months (determined from the date of randomization). b) Treatment response (according to RECIST 1.1). c)To determine the feasibility of treatment selection based on pharmacogenomic parameters in previously untreated patients with advanced NSCLC in a multi-institutional randomized setting. d)To describe the toxicity in patients treated with and without assignment of chemotherapy based on gene expression.;Primary end point(s): The primary endpoint is OS (determined from the date of randomization).;Timepoint(s) of evaluation of this end point: Approximately 60 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) PFS at 6 months (determined from the date of randomization). b) Treatment response (according to RECIST 1.1). 2.2.1 To determine the feasibility of treatment selection based on pharmacogenomic parameters. 2.2.2 To describe the toxicity in patients treated with and without assignment of chemotherapy based on gene expression.;Timepoint(s) of evaluation of this end point: Approximately 60 months | — |
Countries
Italy
Contacts
Public ContactS.C.D.U. ONCOLOGIA POLMONARE
UNIVERSITA' DEGLI STUDI DI TORINO
Outcome results
None listed