Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment

NCT ID: NCT00606502

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-06-24

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)

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pralatrexate

Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).

Group Type: EXPERIMENTAL

Pralatrexate

Intervention Type: DRUG

Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).

Initial dose: 230 mg/m2, increased to 270 mg/m2 if patient does not have specific adverse events (AEs) as per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/m2 decrements to 190 mg/m2 per the protocol defined dose modifications.

Protocol amended dose: 190 mg/m2, then 230 mg/m2 if patient does not have specific AEs per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/2 decrements to 150 mg/m2 per the protocol defined dose modifications.

Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met.

Vitamin B12

Intervention Type: DIETARY_SUPPLEMENT

1 mg intramuscular injection

Administered within 10 weeks of randomization, every 8-10 weeks throughout the study and for at least 30 days after last dose of study treatment.

Folic Acid

Intervention Type: DIETARY_SUPPLEMENT

1-1.25 mg orally

Administered daily for at least 7 days prior to randomization, throughout the study and for at least 30 days after last dose of study treatment.

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.

Group Type: ACTIVE_COMPARATOR

Erlotinib

Intervention Type: DRUG

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.

Vitamin B12

Intervention Type: DIETARY_SUPPLEMENT

1 mg intramuscular injection

Administered within 10 weeks of randomization, every 8-10 weeks throughout the study and for at least 30 days after last dose of study treatment.

Folic Acid

Intervention Type: DIETARY_SUPPLEMENT

1-1.25 mg orally

Administered daily for at least 7 days prior to randomization, throughout the study and for at least 30 days after last dose of study treatment.

Interventions

Pralatrexate

Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride).

Initial dose: 230 mg/m2, increased to 270 mg/m2 if patient does not have specific adverse events (AEs) as per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/m2 decrements to 190 mg/m2 per the protocol defined dose modifications.

Protocol amended dose: 190 mg/m2, then 230 mg/m2 if patient does not have specific AEs per the protocol after receipt of 2 consecutive doses 2 weeks apart. Reductions allowed in 40 mg/2 decrements to 150 mg/m2 per the protocol defined dose modifications.

Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Vitamin B12

1 mg intramuscular injection

Administered within 10 weeks of randomization, every 8-10 weeks throughout the study and for at least 30 days after last dose of study treatment.

Intervention Type: DIETARY_SUPPLEMENT

Folic Acid

1-1.25 mg orally

Administered daily for at least 7 days prior to randomization, throughout the study and for at least 30 days after last dose of study treatment.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

FOLOTYN; PDX; (RS)-10-propargyl-10-deazaaminopterin; Tarceva®; Erlotinib hydrochloride; Cyanocobalamin; Vitamin B9; Folate; Folacin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectrum Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Garry Weems, PharmD

Role: STUDY_DIRECTOR

Spectrum Pharmaceuticals, Inc

Locations

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Donald Berdeaux

Great Falls, Montana, United States

Summit Medical Group

Berkeley Heights, New Jersey, United States

Hematology and Oncology Associates South Jersey

Mount Holly, New Jersey, United States

New York Oncology Hematology-Oncology Associates, P.C.

Latham, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

New Bern Cancer Care

New Bern, North Carolina, United States

Signal Point Clinical Research Center

Middletown, Ohio, United States

Baptist Regional Cancer Center

Knoxville, Tennessee, United States

Cancer Therapy and Research Center

San Antonio, Texas, United States

Providence Everett Medical Center

Everett, Washington, United States

Policlinica Privada - Instituto de Medicina Nuclear

Bahía Blanca, 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

CAIPO (Centero Para la Atencion Integral del Paciente Oncologico)

San Miguel de Tucumán, , Argentina

ISIS Clinica Especializada

Santa Fe, , Argentina

Associação Hospital de Caridade de Ijuí

Ijuí, Rio Grande do Sul, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Clinionco - Clínica de Oncologia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital do Câncer de Barretos

Barretos, São Paulo, Brazil

Biocancer S.A.

Belo Horizonte, , Brazil

Instituto do Cancer - Arnaldo Vieira de Carvalho

São Paulo, , Brazil

Masarykuv onkologicky ustav

Brno, , Czechia

Palacký University Medical School and Teaching Hospital

Olomouc, , Czechia

Vitkovicka nemocnice, a. s.

Ostrava, , Czechia

Fakultni nemocnice v Motole

Prague, , Czechia

Nemocnice Na Homolce

Prague, , Czechia

Fakultni nemocnice na Bulovce

Prague, , Czechia

National Koranyi TBC and Pulmonology Institute

Budapest, Pest County, Hungary

Jósa András Teaching Hospital

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

Vas County Markusovszky Hospital

Szombathely, Vas County, Hungary

Zala County Hospital

Zalaegerszeg, Zala County, Hungary

Matrai Allami Gyogyintezet

Mátraháza, , Hungary

Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza

Tatabánya, , Hungary

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

Kidwai Memorial Institute of Oncology

Bangalore, Karnataka, India

Regional Cancer Center

Trivandrum, Kerala, India

Tata Memorial Hospital

Mumbai, Maharashtra, India

Jehangir Clinical Development Centre Pvt Ltd

Pune, Mahara, India

B.P. Poddar Cancer Institute

Kolkata, West Bengal, India

Dharmashila Cancer Hospital & Research Centre

New Delhi, , India

Countries

United States; Argentina; Brazil; Czechia; Hungary; India

Other Identifiers

2007-004673-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PDX-012

Identifier Type: -

Identifier Source: org_study_id