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Trial record 16 of 35 for:    pralatrexate AND cells

Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder

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ClinicalTrials.gov Identifier: NCT00722553
Recruitment Status : Completed
First Posted : July 25, 2008
Results First Posted : July 17, 2012
Last Update Posted : May 10, 2013
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma, Transitional Cell
Bladder Cancer
Bladder Neoplasm
Interventions Drug: Pralatrexate Injection
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic Acid
Enrollment 30
Recruitment Details Patients were enrolled between July 2008 and November 2010 across 10 study sites and 5 countries.
Pre-assignment Details  
Arm/Group Title Full Population
Hide Arm/Group Description Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title Full Population
Hide Arm/Group Description Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  46.7%
>=65 years
16
  53.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
65.8  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
3
  10.0%
Male
27
  90.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
France 14
United States 4
Argentina 1
Spain 10
Belgium 1
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description The number of patients with a best overall confirmed response of either complete response (CR) or partial response (PR)
Time Frame Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended for up to 2 years after enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Population
Hide Arm/Group Description:
All patients who received at least 1 dose of pralatrexate, had histologically confirmed transitional cell carcinoma (TCC) (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title Duration of Response (DOR)
Hide Description Duration of time from when tumor measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent disease or progressive disease (PD) or death was objectively documented. Progression is defined, using RECIST, as an increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. Calculated for those patients with a best overall confirmed or unconfirmed response of CR or PR.
Time Frame Measured from the first day of documented response for up to 2 years after enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol, based on the number of all responding patients both confirmed and unconfirmed (n=5) in the evaluable population (n=30)
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
Overall Number of Participants Analyzed 5
Median (95% Confidence Interval)
Unit of Measure: Days
82
(58 to 120)
3.Secondary Outcome
Title Clinical Benefit Rate (CBR)
Hide Description The number of patients with a best confirmed or unconfirmed response of CR, PR, or stable disease (SD) for at least 24 weeks (approximately 5.5 months)
Time Frame Assessed at the end of each even-numbered cycle (every 8 weeks) or per standard of care, but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Population
Hide Arm/Group Description:
All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
3
4.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Length of time from study day 1 to the date of radiological evidence of PD (date of computed tomography [CT] or magnetic resonance imaging [MRI] scan, whichever indicates PD) or death, regardless of cause.
Time Frame Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored.
Arm/Group Title Evaluable Population
Hide Arm/Group Description:
All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: Months
4.0
(2.1 to 4.5)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description The number of days from study day 1 to death. Patients who had not died (no record of death) or were lost to follow-up were censored at the date of last contact.
Time Frame Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care if treatment has ended (at least every 12 weeks) for up to 2 years after enrollment. After PD or start of subsequent treatment, OS will be assessed every 4 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol. Patients who had not died or were lost to follow-up were censored
Arm/Group Title Evaluable Population
Hide Arm/Group Description:
All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.
Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: Months
9.3
(5.6 to 13.2)
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 Serious AEs and AEs regardless of causality and all grades presented below. Symptoms present at baseline, AEs, and intercurrent illnesses were monitored at every study visit. Patients were instructed to report AEs to the investigator. All AEs including observed or volunteered problems, complaints, or symptoms were recorded.
 
Arm/Group Title Full Population
Hide Arm/Group Description Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.
All-Cause Mortality
Full Population
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Full Population
Affected / at Risk (%)
Total   17/30 (56.67%) 
Blood and lymphatic system disorders   
anaemia  1  2/30 (6.67%) 
neutropenia  1  2/30 (6.67%) 
thrombocytopenia  1  1/30 (3.33%) 
Cardiac disorders   
pericarditis  1  1/30 (3.33%) 
Gastrointestinal disorders   
stomatitis  1  6/30 (20.00%) 
ascites  1  1/30 (3.33%) 
diarrhoea  1  1/30 (3.33%) 
vomiting  1  1/30 (3.33%) 
General disorders   
asthenia  1  2/30 (6.67%) 
general physical health deterioration  1  2/30 (6.67%) 
pyrexia  1  2/30 (6.67%) 
fatigue  1  1/30 (3.33%) 
mucosal inflammation  1  1/30 (3.33%) 
Hepatobiliary disorders   
hyperbilirubinaemia  1  1/30 (3.33%) 
Infections and infestations   
cellulitis  1  1/30 (3.33%) 
infection  1  1/30 (3.33%) 
Injury, poisoning and procedural complications   
renal injury  1  1/30 (3.33%) 
Metabolism and nutrition disorders   
anorexia  1  2/30 (6.67%) 
hypercalcaemia  1  1/30 (3.33%) 
Musculoskeletal and connective tissue disorders   
arthralgia  1  2/30 (6.67%) 
pain in extremity  1  1/30 (3.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
lung infiltration malignant  1  1/30 (3.33%) 
Renal and urinary disorders   
haematuria  1  1/30 (3.33%) 
renal failure  1  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders   
atelectasis  1  1/30 (3.33%) 
pulmonary oedema  1  1/30 (3.33%) 
Skin and subcutaneous tissue disorders   
toxic skin eruption  1  2/30 (6.67%) 
rash pruritic  1  1/30 (3.33%) 
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%
Full Population
Affected / at Risk (%)
Total   30/30 (100.00%) 
Blood and lymphatic system disorders   
anaemia  1  11/30 (36.67%) 
neutropenia  1  7/30 (23.33%) 
thrombocytopenia  1  5/30 (16.67%) 
leukopenia  1  3/30 (10.00%) 
Cardiac disorders   
arrhythmia  1  2/30 (6.67%) 
Gastrointestinal disorders   
stomatitis  1  23/30 (76.67%) 
constipation  1  10/30 (33.33%) 
vomiting  1  10/30 (33.33%) 
nausea  1  8/30 (26.67%) 
abdominal pain  1  6/30 (20.00%) 
diarrhoea  1  4/30 (13.33%) 
aphthous stomatitis  1  3/30 (10.00%) 
abdominal distension  1  2/30 (6.67%) 
ascites  1  2/30 (6.67%) 
dry mouth  1  2/30 (6.67%) 
dysphagia  1  2/30 (6.67%) 
General disorders   
asthenia  1  15/30 (50.00%) 
pyrexia  1  9/30 (30.00%) 
fatigue  1  6/30 (20.00%) 
oedema peripheral  1  6/30 (20.00%) 
general physical health deterioration  1  3/30 (10.00%) 
chest pain  1  2/30 (6.67%) 
hypothermia  1  2/30 (6.67%) 
localised oedema  1  2/30 (6.67%) 
mucosal inflammation  1  2/30 (6.67%) 
Infections and infestations   
infection  1  2/30 (6.67%) 
Investigations   
weight decreased  1  4/30 (13.33%) 
Metabolism and nutrition disorders   
anorexia  1  10/30 (33.33%) 
dehydration  1  3/30 (10.00%) 
hypokalaemia  1  3/30 (10.00%) 
hyperglycaemia  1  2/30 (6.67%) 
Musculoskeletal and connective tissue disorders   
back pain  1  3/30 (10.00%) 
arthralgia  1  2/30 (6.67%) 
musculoskeletal chest pain  1  2/30 (6.67%) 
pain in extremity  1  2/30 (6.67%) 
Nervous system disorders   
dizziness  1  2/30 (6.67%) 
headache  1  2/30 (6.67%) 
Psychiatric disorders   
confusional state  1  2/30 (6.67%) 
Renal and urinary disorders   
renal failure  1  5/30 (16.67%) 
haematuria  1  4/30 (13.33%) 
Reproductive system and breast disorders   
oedema genital  1  2/30 (6.67%) 
pelvic pain  1  2/30 (6.67%) 
Respiratory, thoracic and mediastinal disorders   
dyspnoea  1  6/30 (20.00%) 
cough  1  3/30 (10.00%) 
epistaxis  1  3/30 (10.00%) 
dysphonia  1  2/30 (6.67%) 
pharyngolaryngeal pain  1  2/30 (6.67%) 
Skin and subcutaneous tissue disorders   
alopecia  1  4/30 (13.33%) 
rash papular  1  2/30 (6.67%) 
toxic skin eruption  1  2/30 (6.67%) 
Vascular disorders   
hot flush  1  2/30 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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 trial after the earlier of publication by Allos or 18 months after study completion. Allos can review results communications prior to public release and can embargo communications regarding trial results for a period less than or equal to 90 days from submission for review. Allos can request changes to the communication related to confidential or patent information, or to ensure accuracy.
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: NCT00722553     History of Changes
Other Study ID Numbers: PDX-011
2007-004671-19 ( EudraCT Number )
First Submitted: July 23, 2008
First Posted: July 25, 2008
Results First Submitted: April 30, 2012
Results First Posted: July 17, 2012
Last Update Posted: May 10, 2013