Non-small Cell Lung CancerPhase 2NCT00606502
Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment
A Phase 2 study testing Pralatrexate, Erlotinib and Vitamin B12 in people with Non-small Cell Lung Cancer, run by Spectrum Pharmaceuticals, Inc at 47 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Pralatrexate, Erlotinib and Vitamin B12
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 47 sitesin 6 countries
- Study dates
- Jan 2008to 24 Jun 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
47 sites in 6 countries.
47 sites in 6 countries
United States15 sites
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Summit Medical Group
Berkeley Heights, New Jersey, 07922
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Providence Everett Medical Center
Everett, Washington, 98201
Donald Berdeaux
Great Falls, Montana, 59405
Baptist Regional Cancer Center
Knoxville, Tennessee, 37920
New York Oncology Hematology-Oncology Associates, P.C.
Latham, New York, 12110
Signal Point Clinical Research Center
Middletown, Ohio, 45042
Hematology and Oncology Associates South Jersey
Mount Holly, New Jersey, 08060
New Bern Cancer Care
New Bern, North Carolina, 28562
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Cancer Therapy and Research Center
San Antonio, Texas, 78229
Sharp Memorial Hospital
San Diego, California, 92123
University of Kansas Cancer Center
Westwood, Kansas, 66205
India8 sites
Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, 560029
MNJ Radium Hospital and Radium Institute of Oncology and Regional Cancer Centre
Hyderabaad, Andhra Pradesh, 500004
Indo American Cancer Institute and Research Center
Hyderabad, Andhra Pradesh, 500034
B.P. Poddar Cancer Institute
Kolkata, West Bengal, 700053
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Dharmashila Cancer Hospital & Research Centre
New Delhi, 110096
Jehangir Clinical Development Centre Pvt Ltd
Pune, Mahara, 411001
Regional Cancer Center
Trivandrum, Kerala, 695011
Argentina6 sites
Policlinica Privada - Instituto de Medicina Nuclear
Bahía Blanca, Buenos Aires, B8000FJI
Instituto Medico Especializado Alexander Fleming
Buenos Aires, Cuidad de Buenos Aires, C1426ANZ
Hospital Britanico
Capital Federal, C1280AEB
Centro Oncologico Rosario
Rosario, S2000DSK
CAIPO (Centero Para la Atencion Integral del Paciente Oncologico)
San Miguel de Tucumán, 4000
ISIS Clinica Especializada
Santa Fe, S3000FFU
Brazil6 sites
Fundação Pio XII - Hospital do Câncer de Barretos
Barretos, São Paulo, 14780-400
Biocancer S.A.
Belo Horizonte, 30150-270
Associação Hospital de Caridade de Ijuí
Ijuí, Rio Grande do Sul, 98700-000
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Clinionco - Clínica de Oncologia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90430-090
Instituto do Cancer - Arnaldo Vieira de Carvalho
São Paulo, 01224-010
Czechia6 sites
Masarykuv onkologicky ustav
Brno, 656 53
Palacký University Medical School and Teaching Hospital
Olomouc, 775 20
Vitkovicka nemocnice, a. s.
Ostrava, 703 84
Fakultni nemocnice v Motole
Prague, 150 06
Nemocnice Na Homolce
Prague, 15003
Fakultni nemocnice na Bulovce
Prague, 180 00
Hungary6 sites
National Koranyi TBC and Pulmonology Institute
Budapest, Pest County, 1525
Matrai Allami Gyogyintezet
Mátraháza, 3233
Jósa András Teaching Hospital
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4412
Vas County Markusovszky Hospital
Szombathely, Vas County, 9700
Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza
Tatabánya, 2800
Zala County Hospital
Zalaegerszeg, Zala County, 8900
About this study
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
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
- Being tested
- Pralatrexate, Erlotinib, Vitamin B12, Folic Acid
- Keywords
- Stage IIIB/IV non-small cell lung cancer, Non-small cell lung cancer, NSCLC, Lung Cancer, Pralatrexate, Erlotinib, Tarceva, PDX, Smoking, Smoker
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PralatrexateDrug
Also called FOLOTYN, PDX, (RS)-10-propargyl-10-deazaaminopterin
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.
ErlotinibDrug
Also called Tarceva®, Erlotinib hydrochloride
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 B12Dietary supplement
Also called Cyanocobalamin
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 AcidDietary supplement
Also called Vitamin B9, Folate, Folacin
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.
| Study group | Role | What they receive |
|---|---|---|
| Pralatrexate | Experimental | Intravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Receives: Drug: Pralatrexate; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid |
| Erlotinib | Active comparator | 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. Receives: Drug: Erlotinib; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.
Secondary outcomes (3)
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).
Measured: 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.
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.
Measured: 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.
Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2008 (estimated)
- Study startJan 2008
- Primary completion24 Jun 2010
- Study completion24 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Garry Weems, PharmD, Study director, Spectrum Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606502
- Sponsor's protocol ID
- PDX-012
- Other IDs
- 2007-004673-26
- Status last verified
- Feb 2021
- First submitted
- 22 Jan 2008
- Last updated
- 5 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00606502
- Acronym / sponsor ID
- PDX-012
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- 24 Jun 2010 (actual)
- Study completion
- 24 Jun 2010 (actual)
- First posted
- 4 Feb 2008 (estimated)
- Results
- Posted 20 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pralatrexate | Experimental | Drug: Pralatrexate, Dietary Supplement: Vitamin B12, Dietary Supplement: Folic AcidIntravenous (IV) push administration over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). |
| Erlotinib | Active comparator | Drug: Erlotinib, Dietary Supplement: Vitamin B12, Dietary Supplement: Folic Acid150 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PralatrexateAlso: FOLOTYN, PDX, (RS)-10-propargyl-10-deazaaminopterinIntravenous (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. | Drug | Pralatrexate |
| ErlotinibAlso: Tarceva®, Erlotinib hydrochloride150 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. | Drug | Erlotinib |
| Vitamin B12Also: Cyanocobalamin1 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. | Dietary supplement | Erlotinib, Pralatrexate |
| Folic AcidAlso: Vitamin B9, Folate, Folacin1-1.25 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. | Dietary supplement | Erlotinib, Pralatrexate |
Primary outcome
Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib
Time frame: 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.
3 secondary outcomes
Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib
Time frame: 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.
Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib
Time frame: 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.
Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garry Weems, PharmD study director
Spectrum Pharmaceuticals, Inc
47 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pralatrexate, Erlotinib and Vitamin B12 in people with Non-small Cell Lung Cancer, run by Spectrum Pharmaceuticals, Inc at 47 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, India, Argentina, Brazil, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib (time frame: Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.