Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00606502
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pralatrexate Folic Acid Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Erlotinib Vitamin B12 150 mg orally in tablet form Administered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met. Pralatrexate Vitamin B12 Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Erlotinib Folic Acid 150 mg orally in tablet form Administered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met. Pralatrexate Pralatrexate Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Erlotinib Erlotinib 150 mg orally in tablet form Administered daily 1 hour before or 2 hours after ingestion of food until criteria for discontinuation per the protocol are met.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization. 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.
- Secondary Outcome Measures
Name Time Method Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib 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. Number of patients whose tumors responded to Pralatrexate or Erlotinib, using the Response Criteria in Solid Tumors (RECIST).
Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib 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. PFS was calculated as the number of days from randomization to the date of radiological evidence of PD or death due to any cause.
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).
Trial Locations
- Locations (47)
Donald Berdeaux
🇺🇸Great Falls, Montana, United States
Instituto Medico Especializado Alexander Fleming
🇦🇷Buenos Aires, Cuidad De Buenos Aires, Argentina
Policlinica Privada - Instituto de Medicina Nuclear
🇦🇷Bahia Blanca, Provincia De Buenos Aires, Argentina
Centro Oncologico Rosario
🇦🇷Rosario, Argentina
ISIS Clinica Especializada
🇦🇷Santa Fe, Argentina
Zala County Hospital
🇭🇺Zalaegerszeg, Zala, Hungary
Regional Cancer Center
🇮🇳Trivandrum, Kerala, India
Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza
🇭🇺Tatabánya, Hungary
Jehangir Clinical Development Centre Pvt Ltd
🇮🇳Pune, Mahara, India
MNJ Radium Hospital and Radium Institute of Oncology and Regional Cancer Centre
🇮🇳Hyderabaad, Andhra Pradesh, India
Kidwai Memorial Institute of Oncology
🇮🇳Bangalore, Karnataka, India
Dharmashila Cancer Hospital & Research Centre
🇮🇳New Delhi, India
Hematology Oncology Associates of the Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
New Bern Cancer Care
🇺🇸New Bern, North Carolina, United States
Hematology and Oncology Associates South Jersey
🇺🇸Mount Holly, New Jersey, United States
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Signal Point Clinical Research Center
🇺🇸Middletown, Ohio, United States
Masarykuv onkologicky ustav
🇨🇿Brno, Czechia
Instituto do Cancer - Arnaldo Vieira de Carvalho
🇧🇷Sao Paulo, Brazil
B.P. Poddar Cancer Institute
🇮🇳Kolkata, West Bengal, India
Tata Memorial Hospital
🇮🇳Mumbai, Maharashtra, India
Fakultni nemocnice na Bulovce
🇨🇿Praha 8, Czechia
Fundação Pio XII - Hospital do Câncer de Barretos
🇧🇷Barretos, SP, Brazil
Vitkovicka nemocnice, a. s.
🇨🇿Ostrava, Czechia
Hospital Britanico
🇦🇷Capital Federal, Argentina
Providence Everett Medical Center
🇺🇸Everett, Washington, United States
Associação Hospital de Caridade de Ijuí
🇧🇷Ijui, RS, Brazil
National Koranyi TBC and Pulmonology Institute
🇭🇺Budapest, Pest, Hungary
Matrai Allami Gyogyintezet
🇭🇺Matrahaza, Hungary
Biocancer S.A.
🇧🇷Belo Horizonte, Brazil
New York Oncology Hematology-Oncology Associates, P.C.
🇺🇸Latham, New York, United States
Palacký University Medical School and Teaching Hospital
🇨🇿Olomouc, Czechia
Clinionco - Clínica de Oncologia de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Cancer Therapy and Research Center
🇺🇸San Antonio, Texas, United States
Baptist Regional Cancer Center
🇺🇸Knoxville, Tennessee, United States
Summit Medical Group
🇺🇸Berkeley Heights, New Jersey, United States
CAIPO (Centero Para la Atencion Integral del Paciente Oncologico)
🇦🇷Tucuman, Argentina
Vas County Markusovszky Hospital
🇭🇺Szombathely, Vas, Hungary
Nemocnice Na Homolce
🇨🇿Praha, Czechia
Jósa András Teaching Hospital
🇭🇺Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary
Indo American Cancer Institute and Research Center
🇮🇳Hyderabad, Andhra Pradesh, India
Fakultni nemocnice v Motole
🇨🇿Praha, Czechia
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States