Clinical trial NCT00606502: Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Stage IIIB/IV non-small cell lung cancer
Non-small cell lung cancer
NSCLC
Lung Cancer
Pralatrexate
Erlotinib
Tarceva
PDX
Smoking
Smoker
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2008-02-04
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib
timeFrame: Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.
Secondary outcomes:
measure: Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib
timeFrame: 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.
measure: Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib
timeFrame: 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.
measure: Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib
timeFrame: 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).
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Great Falls
country: United States
facility: Donald Berdeaux
state: Montana
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Mount Holly
country: United States
facility: Hematology and Oncology Associates South Jersey
state: New Jersey
city: Latham
country: United States
facility: New York Oncology Hematology-Oncology Associates, P.C.
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New Bern
country: United States
facility: New Bern Cancer Care
state: North Carolina
city: Middletown
country: United States
facility: Signal Point Clinical Research Center
state: Ohio
city: Knoxville
country: United States
facility: Baptist Regional Cancer Center
state: Tennessee
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center
state: Texas
city: Everett
country: United States
facility: Providence Everett Medical Center
state: Washington
city: Buenos Aires
country: Argentina
facility: Instituto Medico Especializado Alexander Fleming
state: Cuidad De Buenos Aires
city: Bahia Blanca
country: Argentina
facility: Policlinica Privada - Instituto de Medicina Nuclear
state: Provincia De Buenos Aires
city: Capital Federal
country: Argentina
facility: Hospital Britanico
city: Rosario
country: Argentina
facility: Centro Oncologico Rosario
city: Santa Fe
country: Argentina
facility: ISIS Clinica Especializada
city: Tucuman
country: Argentina
facility: CAIPO (Centero Para la Atencion Integral del Paciente Oncologico)
city: Ijui
country: Brazil
facility: Associação Hospital de Caridade de Ijuí
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Clinionco - Clínica de Oncologia de Porto Alegre
state: RS
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital do Câncer de Barretos
state: SP
city: Belo Horizonte
country: Brazil
facility: Biocancer S.A.
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer - Arnaldo Vieira de Carvalho
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Olomouc
country: Czechia
facility: Palacký University Medical School and Teaching Hospital
city: Ostrava
country: Czechia
facility: Vitkovicka nemocnice, a. s.
city: Praha 8
country: Czechia
facility: Fakultni nemocnice na Bulovce
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole
city: Praha
country: Czechia
facility: Nemocnice Na Homolce
city: Budapest
country: Hungary
facility: National Koranyi TBC and Pulmonology Institute
state: Pest
city: Nyiregyhaza
country: Hungary
facility: Jósa András Teaching Hospital
state: Szabolcs-Szatmár-Bereg
city: Szombathely
country: Hungary
facility: Vas County Markusovszky Hospital
state: Vas
city: Zalaegerszeg
country: Hungary
facility: Zala County Hospital
state: Zala
city: Matrahaza
country: Hungary
facility: Matrai Allami Gyogyintezet
city: Tatabánya
country: Hungary
facility: Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza
city: Hyderabaad
country: India
facility: MNJ Radium Hospital and Radium Institute of Oncology and Regional Cancer Centre
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Indo American Cancer Institute and Research Center
state: Andhra Pradesh
city: Bangalore
country: India
facility: Kidwai Memorial Institute of Oncology
state: Karnataka
city: Trivandrum
country: India
facility: Regional Cancer Center
state: Kerala
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
city: Pune
country: India
facility: Jehangir Clinical Development Centre Pvt Ltd
state: Mahara
city: Kolkata
country: India
facility: B.P. Poddar Cancer Institute
state: West Bengal
city: New Delhi
country: India
facility: Dharmashila Cancer Hospital & Research Centre
Study officials:
affiliation: Spectrum Pharmaceuticals, Inc
name: Garry Weems, PharmD
role: STUDY_DIRECTOR
References: