Trial record 1 of 27 for:    pralatrexate
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Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00606502
First received: January 22, 2008
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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)


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Pralatrexate Injection
Drug: Erlotinib
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • 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. ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]
    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 [ 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). ] [ Designated as safety issue: Yes ]

Enrollment: 201
Study Start Date: January 2008
Study Completion Date: August 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pralatrexate Drug: Pralatrexate Injection

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.

Other Names:
  • FOLOTYN
  • PDX
  • Pralatrexate
  • (RS)-10-propargyl-10-deazaaminopterin
Dietary Supplement: 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.

Other Name: Cyanocobalamin
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.

Other Names:
  • Vitamin B9
  • Folate
  • Folacin
Active Comparator: Erlotinib 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.

Other Names:
  • Tarceva®
  • Erlotinib hydrochloride
Dietary Supplement: 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.

Other Name: Cyanocobalamin
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.

Other Names:
  • Vitamin B9
  • Folate
  • Folacin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606502

  Show 47 Study Locations
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Director: Garry Weems, PharmD Spectrum Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00606502     History of Changes
Other Study ID Numbers: PDX-012, 2007-004673-26
Study First Received: January 22, 2008
Results First Received: December 22, 2010
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
India: Ministry of Health

Keywords provided by Spectrum Pharmaceuticals, Inc:
Stage IIIB/IV non-small cell lung cancer
Non-small cell lung cancer
NSCLC
Lung Cancer
Pralatrexate
Erlotinib
Tarceva
PDX
Smoking
Smoker

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Folic Acid
Hydroxocobalamin
Vitamin B Complex
Vitamin B 12
Vitamins
10-deazaaminopterin
Aminopterin
Erlotinib
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014