Non-small Cell Lung Cancer Clinical Trial
Official title:
A Randomized, Phase 2b, Multi-center Study of Pralatrexate Versus Erlotinib in Patients With Stage IIIB/IV Non-small Cell Lung Cancer After Failure of at Least 1 Prior Platinum-based Treatment
Verified date | February 2021 |
Source | Spectrum Pharmaceuticals, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this clinical study is to determine the effectiveness (ability to provide beneficial treatment of the disease) and safety of pralatrexate compared to erlotinib when given to non-small cell lung cancer (NSCLC) patients who are current or former cigarette smokers and who have received at least 1 prior treatment with a platinum drug (cisplatin or carboplatin)
Status | Completed |
Enrollment | 201 |
Est. completion date | June 24, 2010 |
Est. primary completion date | June 24, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Confirmed Stage IIIB/ IV non-small cell lung cancer (NSCLC). - Relapsed after treatment with 1 or 2 prior chemotherapy regimens, including at least 1 platinum-based treatment. Patients may have received pemetrexed as 1 of the prior therapies. Patients may not have received investigational therapy as their only prior therapy. - Recovered from the toxic effects of prior therapy. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Smoked = 100 cigarettes in their lifetime, whether a former or current cigarette smoker. - Adequate blood, liver and kidney function as defined by laboratory values. - Received 1-1.25 mg daily oral folic acid for at least 7 days prior to randomization and 1 mg intramuscular injection of vitamin B12 within 10 weeks prior to randomization. - Women of childbearing potential must use medically acceptable birth control and have a negative serum pregnancy test within 14 days prior to randomization. Patients who are postmenopausal for at least 1 year (> 12 months since last menses) or are surgically sterilized do not require this test. - Men who are not surgically sterile must use medically safe and effective birth control from the time of study randomization, and agree to continue practicing until at least 90 days after the last administration of study treatment. - Accessible for repeat dosing and follow-up. - Give written informed consent. Exclusion Criteria: - Active concurrent primary malignancy (except non-melanoma skin cancer or in situ carcinoma of the cervix). If there is a history of prior malignancy, the patient must be disease-free for = 5 years. Patients with other prior malignancies less than 5 years before study entry may still be enrolled if they have received treatment resulting in complete resolution of the cancer and currently have no evidence of active or recurrent disease. - Use of investigational drugs, biologics, or devices within 4 weeks prior to randomization. - Previous exposure to pralatrexate or erlotinib. - Women who are pregnant or breastfeeding. - Congestive Heart Failure Class III/IV according to New York Heart Association (NYHA) Functional Classification. - Uncontrolled hypertension. - Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of <100 mm3 or detectable viral load within the past 3 months, and is receiving combination anti-retroviral therapy. - Symptomatic central nervous system metastases or lesions for which treatment is required. - Major surgery within 2 weeks of study randomization. - Receipt of any conventional systemic chemotherapy within 4 weeks (6 weeks for nitrosoureas, mitomycin C), or radiation therapy (RT) within 2 weeks, prior to randomization. - Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment. - Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent or limit study compliance. |
Country | Name | City | State |
---|---|---|---|
Argentina | Policlinica Privada - Instituto de Medicina Nuclear | Bahia Blanca | Provincia De Buenos Aires |
Argentina | Instituto Medico Especializado Alexander Fleming | Buenos Aires | Cuidad De Buenos Aires |
Argentina | Hospital Britanico | Capital Federal | |
Argentina | Centro Oncologico Rosario | Rosario | |
Argentina | ISIS Clinica Especializada | Santa Fe | |
Argentina | CAIPO (Centero Para la Atencion Integral del Paciente Oncologico) | Tucuman | |
Brazil | Fundação Pio XII - Hospital do Câncer de Barretos | Barretos | SP |
Brazil | Biocancer S.A. | Belo Horizonte | |
Brazil | Associação Hospital de Caridade de Ijuí | Ijui | RS |
Brazil | Clinionco - Clínica de Oncologia de Porto Alegre | Porto Alegre | RS |
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | RS |
Brazil | Instituto do Cancer - Arnaldo Vieira de Carvalho | Sao Paulo | |
Czechia | Masarykuv onkologicky ustav | Brno | |
Czechia | Palacký University Medical School and Teaching Hospital | Olomouc | |
Czechia | Vitkovicka nemocnice, a. s. | Ostrava | |
Czechia | Fakultni nemocnice v Motole | Praha | |
Czechia | Nemocnice Na Homolce | Praha | |
Czechia | Fakultni nemocnice na Bulovce | Praha 8 | |
Hungary | National Koranyi TBC and Pulmonology Institute | Budapest | Pest |
Hungary | Matrai Allami Gyogyintezet | Matrahaza | |
Hungary | Jósa András Teaching Hospital | Nyiregyhaza | Szabolcs-Szatmár-Bereg |
Hungary | Vas County Markusovszky Hospital | Szombathely | Vas |
Hungary | Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza | Tatabánya | |
Hungary | Zala County Hospital | Zalaegerszeg | Zala |
India | Kidwai Memorial Institute of Oncology | Bangalore | Karnataka |
India | MNJ Radium Hospital and Radium Institute of Oncology and Regional Cancer Centre | Hyderabaad | Andhra Pradesh |
India | Indo American Cancer Institute and Research Center | Hyderabad | Andhra Pradesh |
India | B.P. Poddar Cancer Institute | Kolkata | West Bengal |
India | Tata Memorial Hospital | Mumbai | Maharashtra |
India | Dharmashila Cancer Hospital & Research Centre | New Delhi | |
India | Jehangir Clinical Development Centre Pvt Ltd | Pune | Mahara |
India | Regional Cancer Center | Trivandrum | Kerala |
United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
United States | Summit Medical Group | Berkeley Heights | New Jersey |
United States | Northwestern University Feinberg School of Medicine | Chicago | Illinois |
United States | Providence Everett Medical Center | Everett | Washington |
United States | Donald Berdeaux | Great Falls | Montana |
United States | Baptist Regional Cancer Center | Knoxville | Tennessee |
United States | New York Oncology Hematology-Oncology Associates, P.C. | Latham | New York |
United States | Signal Point Clinical Research Center | Middletown | Ohio |
United States | Hematology and Oncology Associates South Jersey | Mount Holly | New Jersey |
United States | New Bern Cancer Care | New Bern | North Carolina |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida |
United States | Cancer Therapy and Research Center | San Antonio | Texas |
United States | Sharp Memorial Hospital | San Diego | California |
United States | University of Kansas Cancer Center | Westwood | Kansas |
Lead Sponsor | Collaborator |
---|---|
Spectrum Pharmaceuticals, Inc |
United States, Argentina, Brazil, Czechia, Hungary, India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib | OS was defined as the length of time from randomization until death due to any cause. Patients who were alive at the time of the data cut-off date were censored at the last contact date. | Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization. | |
Secondary | Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib | Number of patients whose tumors responded to Pralatrexate or Erlotinib, using the Response Criteria in Solid Tumors (RECIST). | Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment. | |
Secondary | Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib | PFS was calculated as the number of days from randomization to the date of radiological evidence of PD or death due to any cause. | Assessed every 8 weeks for the first 24 weeks, then every 16 weeks for up to 2 years or until PD or start of subsequent treatment. | |
Secondary | Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib | Assessed every 2 weeks while on treatment through safety follow-up visit (35 +/-5 days post-last dose) or early termination visit (at time of withdrawal). |
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