Alimta® Versus Its Combination With Carboplatin in Advanced Non-small-cell Lung Cancer in Patients Performance Status 2

Launched by INSTITUTO NACIONAL DE CANCER, BRAZIL · Apr 18, 2013

Keywords

ClinConnect Summary

This is a Phase III, open label, randomized study to enroll 228 patients with advanced in a 1:1 ratio at the time of registration. Patients in Arm A will receive pemetrexed, 500 mg/m2, with appropriate vitamin supplementation; patients in Arm B will receive the same dose and schedule of pemetrexed as in Arm A, in combination with carboplatin, AUC of 5. For the purpose of the study, treatment (Arm A or Arm B) will consist of up to four cycles of therapy (repeated every 21 days). Primary endpoint of the study is overall survival; secondary endpoints include toxicity, response rate, and progre...

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Eligibility criteria

• Inclusion Criteria:
• • Newly diagnosed NSCLC in stage IIIB (with a cytologically positive pleural or pericardial effusion) or stage IV, according to the sixth edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual37;
• • Age \> 18 years;
• • No prior chemotherapy, including adjuvant or neoadjuvant therapy, for the treatment of NSCLC;
• • Histological confirmation of any non-squamous histological type of NSCLC, given the recent findings of treatment benefit in this population44;
• • ECOG performance status of 2;
• • At least 3 weeks must have elapsed since major surgery, and at least 1 week since mediastinoscopy, pleuroscopy, or thoracostomy;
• • Patients must have measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques (computed tomography \[CT\] or magnetic resonance imaging \[MRI\] scan) or as ≥ 10 mm with spiral CT scan;
• * Adequate organ function as indicated by the following:
• • White blood cell (WBC) count ≥ 3500/mm3
• • Absolute neutrophil count (ANC) ≥1500/mm3
• • Hemoglobin ≥ 9.0 g/dL
• • Platelet count ≥ 100,000/ mm3
• • Total bilirubin ≤ 2 times the upper limit of normal (ULN)
• • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the ULN, unless liver metastases present, in which case AST and ALT have to be ≤ 5 times the ULN
• • Estimated glomerular filtration rate (GFR) ≥ 45 mL/min
• • Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration;
• • Fertile patients (male or female) must agree to use an acceptable method of contraception to avoid pregnancy for the duration of the study and for 3 months thereafter;
• • Patients must sign an Informed Consent Form;
• • Have the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol requirements;
• Exclusion Criteria:
• • ECOG performance status other than 2;
• • Prior chemotherapy for the treatment of NSCLC;
• • Lesions that have been irradiated cannot be included as sites of measurable disease. If the only measurable lesion was previously irradiated the patient cannot be included;
• • Symptomatic central nervous system (CNS) metastases. Prior CNS metastases are allowed if the patient is neurologically stable and not receiving corticosteroids;
• • Serious uncontrolled intercurrent medical or psychiatric illness;
• • Active and ongoing systemic infection;
• • Second primary malignancy (except in situ carcinoma of the cervix, in situ carcinoma of the bladder, adequately treated basal-cell carcinoma of the skin, adequately treated squamous-cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment and without recurrence);
• • Known hypersensitivity to pemetrexed;
• • known hypersensitivity to carboplatin;
• • Pregnancy or lactation;
• • Use of any investigational agent within 30 days prior to enrollment into the study;
• • Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDSs) agents for 2 days before, the day of and 2 days after the dose of pemetrexed, in the case of NSAIDs with short half-life, such as ibuprofen (total of 5 days), in patients with a GFR between 45 and 79 mL/min; and for 5 days before, the day of and 2 days after the dose of pemetrexed, in the case of NSAIDs with long half-life (total of 8 days, see 7.4.2) in all patients; patients with a GFR ≥ 80 mL/min may receive concomitant study treatment and ibuprofen or aspirin (≤ 1.3 g/day);
• • Inability to comply with requirements and procedures of study.