Status:
COMPLETED
Alimta® Versus Its Combination With Carboplatin in Advanced Non-small-cell Lung Cancer in Patients Performance Status 2
Lead Sponsor:
Instituto Nacional de Cancer, Brazil
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Non Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Optimal management of patients with advanced NSCLC and with PS 2 remains controversial and underrepresented in clinical trials, typically accounting for 5 to 10% of enrolled patients. Patient PS 2 pro...
Detailed Description
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 appropriat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT01836575
Start Date
April 1 2008
End Date
December 1 2012
Last Update
April 22 2013
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
The Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
2
Instituto do Câncer do Ceará - ICC
Fortaleza, Ceará, Brazil
3
Hospital Lifecenter
Belo Horizonte, Minas Gerais, Brazil
4
INCA
Rio de Janeiro, Rio de Janeiro, Brazil