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Trial record 14 of 37 for:    pralatrexate

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

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ClinicalTrials.gov Identifier: NCT00606502
Recruitment Status : Completed
First Posted : February 4, 2008
Results First Posted : January 20, 2011
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Interventions Drug: Pralatrexate
Drug: Erlotinib
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic Acid
Enrollment 201
Recruitment Details Patients were enrolled between January 2008 and June 2009 across 43 study sites in 6 countries.
Pre-assignment Details  
Arm/Group Title Pralatrexate Erlotinib
Hide Arm/Group Description 190 or 230 mg/m2 starting dose with increases or decreases to 150 to 270 mg/m2 per protocol, administered as an IV push over 3-5 minutes on days 1 and 15 of a 4-week cycle (ie, every 2 weeks) 150 mg tablet taken orally daily
Period Title: Randomization
Started 100 101
Completed 97 101
Not Completed 3 0
Reason Not Completed
Randomized but not treated             3             0
Period Title: Treatment
Started 97 101
Completed 97 98
Not Completed 0 3
Reason Not Completed
Treatment ongoing at time of data cutoff             0             3
Arm/Group Title Pralatrexate Erlotinib Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 100 101 201
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 101 participants 201 participants
Between 18 and 65 years 58 60 118
>=65 years 42 41 83
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 101 participants 201 participants
63.0  (9.0) 62.0  (9.1) 63.0  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 101 participants 201 participants
Female
31
  31.0%
33
  32.7%
64
  31.8%
Male
69
  69.0%
68
  67.3%
137
  68.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 101 participants 201 participants
United States 31 37 68
Czech Republic 17 20 37
Hungary 17 15 32
India 11 12 23
Brazil 13 9 22
Argentina 11 8 19
1.Primary Outcome
Title Overall Survival (OS) of Patients Receiving Pralatrexate vs. Erlotinib
Hide Description 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.
Time Frame Assessed from date of randomization no less frequently than every 16 weeks for up to 2 years after randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pralatrexate Erlotinib
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 100 101
Median (95% Confidence Interval)
Unit of Measure: Months Survival
6.7
(5.3 to 9.0)
7.0
(3.9 to 7.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pralatrexate, Erlotinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.61 to 1.14
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Response Rate (RR) to Treatment of Patients Receiving Pralatrexate vs. Erlotinib
Hide Description Number of patients whose tumors responded to Pralatrexate or Erlotinib, using the Response Criteria in Solid Tumors (RECIST).
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Based on all treated patients with measurable disease at baseline. Patients who were declared unevaluable for response were considered nonresponders and were included in the calculation of response rate. Patients were unevaluable if they were off-treatment prior to first response assessment, never received treatment or had unconfirmed responses.
Arm/Group Title Pralatrexate Erlotinib
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 97 98
Measure Type: Number
Unit of Measure: Participants
Complete + Partial Response 2 7
Complete Response (CR) 0 1
Partial Response (PR) 2 6
Stable Disease (SD) 33 35
Progressive Disease (PD) 29 36
Disease Control (CR+PR+SD) 35 42
Unable to Evaluate 2 0
Missing (off or no treatment, not confirmed) 31 20
3.Secondary Outcome
Title Progression-free Survival (PFS) of Patients Receiving Pralatrexate vs. Erlotinib
Hide Description PFS was calculated as the number of days from randomization to the date of radiological evidence of PD or death due to any cause.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were alive without a disease response assessment of PD as of the data cut-off date were censored at the last disease assessment date or the date of randomization, whichever was later. Patients with no response assessments after baseline were censored at date of randomization resulting in a duration of PFS of 1 day.
Arm/Group Title Pralatrexate Erlotinib
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 100 101
Median (95% Confidence Interval)
Unit of Measure: months
3.4
(2.1 to 4.7)
2.8
(2.1 to 3.7)
4.Secondary Outcome
Title Adverse Events of Patients Receiving Pralatrexate vs. Erlotinib
Hide Description [Not Specified]
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).
Hide Outcome Measure Data
Hide Analysis Population Description

Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Pralatrexate or Erlotinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.

Grade 3 = Severe

Grade 4 = Life-threatening or disabling

Arm/Group Title Pralatrexate Erlotinib
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 97 101
Measure Type: Number
Unit of Measure: Treated Participants
At least one AE 75 77
Grade 3 AEs 25 18
Grade 4 AEs 5 0
At least one SAE 14 2
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).
Adverse Event Reporting Description Events reported for all patients who received at least one dose of Pralatrexate or Erlotinib.
 
Arm/Group Title Pralatrexate Erlotinib
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Pralatrexate Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pralatrexate Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   31/97 (31.96%)   32/101 (31.68%) 
Blood and lymphatic system disorders     
thrombocytopenia  1  4/97 (4.12%)  0/101 (0.00%) 
leukopenia  1  3/97 (3.09%)  0/101 (0.00%) 
anaemia  1  2/97 (2.06%)  0/101 (0.00%) 
neutropenia  1  1/97 (1.03%)  0/101 (0.00%) 
pancytopenia  1  1/97 (1.03%)  0/101 (0.00%) 
Cardiac disorders     
pericardial effusion  1  1/97 (1.03%)  2/101 (1.98%) 
atrial fibrillation  1  1/97 (1.03%)  1/101 (0.99%) 
cardio-respiratory arrest  1  1/97 (1.03%)  1/101 (0.99%) 
Gastrointestinal disorders     
stomatitis  1  9/97 (9.28%)  0/101 (0.00%) 
abdominal pain  1  0/97 (0.00%)  3/101 (2.97%) 
diarrhoea  1  1/97 (1.03%)  1/101 (0.99%) 
gastrointestinal haemorrhage  1  1/97 (1.03%)  1/101 (0.99%) 
vomiting  1  0/97 (0.00%)  2/101 (1.98%) 
anal inflammation  1  1/97 (1.03%)  0/101 (0.00%) 
dysphagia  1  0/97 (0.00%)  1/101 (0.99%) 
nausea  1  0/97 (0.00%)  1/101 (0.99%) 
General disorders     
pyrexia  1  2/97 (2.06%)  4/101 (3.96%) 
asthenia  1  0/97 (0.00%)  1/101 (0.99%) 
fatigue  1  1/97 (1.03%)  0/101 (0.00%) 
multimorbidity  1  1/97 (1.03%)  0/101 (0.00%) 
non-cardiac chest pain  1  0/97 (0.00%)  1/101 (0.99%) 
sudden death  1  1/97 (1.03%)  0/101 (0.00%) 
Hepatobiliary disorders     
bile duct obstruction  1  1/97 (1.03%)  0/101 (0.00%) 
hyperbilirubinaemia  1  1/97 (1.03%)  0/101 (0.00%) 
Infections and infestations     
sepsis  1  3/97 (3.09%)  3/101 (2.97%) 
pneumonia  1  2/97 (2.06%)  3/101 (2.97%) 
respiratory tract infection  1  1/97 (1.03%)  1/101 (0.99%) 
chest wall abscess  1  0/97 (0.00%)  1/101 (0.99%) 
infection  1  1/97 (1.03%)  0/101 (0.00%) 
influenza  1  1/97 (1.03%)  0/101 (0.00%) 
pulmonary sepsis  1  0/97 (0.00%)  1/101 (0.99%) 
septic shock  1  1/97 (1.03%)  0/101 (0.00%) 
urosepsis  1  0/97 (0.00%)  1/101 (0.99%) 
Injury, poisoning and procedural complications     
femur fracture  1  1/97 (1.03%)  1/101 (0.99%) 
Metabolism and nutrition disorders     
dehydration  1  1/97 (1.03%)  4/101 (3.96%) 
anorexia  1  0/97 (0.00%)  1/101 (0.99%) 
hypoglycaemia  1  0/97 (0.00%)  1/101 (0.99%) 
hyponatraemia  1  1/97 (1.03%)  0/101 (0.00%) 
Musculoskeletal and connective tissue disorders     
musculoskeletal chest pain  1  1/97 (1.03%)  2/101 (1.98%) 
arthralgia  1  1/97 (1.03%)  0/101 (0.00%) 
back pain  1  0/97 (0.00%)  1/101 (0.99%) 
flank pain  1  0/97 (0.00%)  1/101 (0.99%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
cancer pain  1  0/97 (0.00%)  1/101 (0.99%) 
renal cell carcinoma  1  0/97 (0.00%)  1/101 (0.99%) 
Nervous system disorders     
convulsion  1  1/97 (1.03%)  3/101 (2.97%) 
cerebral infarction  1  0/97 (0.00%)  1/101 (0.99%) 
headache  1  1/97 (1.03%)  0/101 (0.00%) 
Psychiatric disorders     
confusional state  1  1/97 (1.03%)  0/101 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
dyspnoea  1  5/97 (5.15%)  4/101 (3.96%) 
respiratory failure  1  5/97 (5.15%)  1/101 (0.99%) 
haemoptysis  1  1/97 (1.03%)  1/101 (0.99%) 
hypoxia  1  1/97 (1.03%)  1/101 (0.99%) 
acute respiratory distress syndrome  1  1/97 (1.03%)  0/101 (0.00%) 
aspiration  1  0/97 (0.00%)  1/101 (0.99%) 
pleural effusion  1  0/97 (0.00%)  1/101 (0.99%) 
pneumonitis  1  1/97 (1.03%)  0/101 (0.00%) 
pneumothorax  1  0/97 (0.00%)  1/101 (0.99%) 
respiratory distress  1  1/97 (1.03%)  0/101 (0.00%) 
Vascular disorders     
arterial thrombosis  1  0/97 (0.00%)  1/101 (0.99%) 
deep vein thrombosis  1  1/97 (1.03%)  0/101 (0.00%) 
hypotension  1  1/97 (1.03%)  0/101 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pralatrexate Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   91/97 (93.81%)   94/101 (93.07%) 
Blood and lymphatic system disorders     
anaemia  1  20/97 (20.62%)  12/101 (11.88%) 
thrombocytopenia  1  12/97 (12.37%)  1/101 (0.99%) 
Eye disorders     
conjunctivitis  1  6/97 (6.19%)  5/101 (4.95%) 
Gastrointestinal disorders     
stomatitis  1  62/97 (63.92%)  4/101 (3.96%) 
diarrhoea  1  15/97 (15.46%)  32/101 (31.68%) 
nausea  1  12/97 (12.37%)  17/101 (16.83%) 
vomiting  1  10/97 (10.31%)  10/101 (9.90%) 
constipation  1  3/97 (3.09%)  8/101 (7.92%) 
General disorders     
fatigue  1  25/97 (25.77%)  16/101 (15.84%) 
asthenia  1  15/97 (15.46%)  8/101 (7.92%) 
oedema peripheral  1  5/97 (5.15%)  7/101 (6.93%) 
Infections and infestations     
bronchitis  1  5/97 (5.15%)  8/101 (7.92%) 
Investigations     
weight decreased  1  8/97 (8.25%)  10/101 (9.90%) 
Metabolism and nutrition disorders     
anorexia  1  16/97 (16.49%)  19/101 (18.81%) 
hypokalaemia  1  5/97 (5.15%)  8/101 (7.92%) 
Musculoskeletal and connective tissue disorders     
back pain  1  3/97 (3.09%)  10/101 (9.90%) 
musculoskeletal pain  1  4/97 (4.12%)  9/101 (8.91%) 
Respiratory, thoracic and mediastinal disorders     
dyspnoea  1  12/97 (12.37%)  22/101 (21.78%) 
cough  1  11/97 (11.34%)  17/101 (16.83%) 
Skin and subcutaneous tissue disorders     
dermatitis acneiform  1  4/97 (4.12%)  28/101 (27.72%) 
rash maculo-papular  1  4/97 (4.12%)  21/101 (20.79%) 
dry skin  1  2/97 (2.06%)  9/101 (8.91%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
The date of the CRF database cut-off for patients (no further case report form or query data entry) was 24 Jun 2010. As of the CRF data cut-off date, 3 patients, remained on therapy.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Allos agreements with investigators (PIs) may vary. The PI may publish/make public data from the study after the earlier of publication by Allos or 24 months after database lock. Allos is allowed 60 days to review and comment on the communication prior to public release. Allos can request removal of confidential information (other than study results).
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Monitor
Organization: Allos Therapeutics, Inc
Phone: 303-426-6262
EMail: gweems@allos.com
Layout table for additonal information
Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00606502     History of Changes
Other Study ID Numbers: PDX-012
2007-004673-26 ( EudraCT Number )
First Submitted: January 22, 2008
First Posted: February 4, 2008
Results First Submitted: December 22, 2010
Results First Posted: January 20, 2011
Last Update Posted: June 30, 2015