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Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT00971841
Recruitment Status : Completed
First Posted : September 4, 2009
Results First Posted : July 19, 2013
Last Update Posted : July 26, 2013
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Esophageal Cancer
Intervention Drug: Paclitaxel
Enrollment 1
Recruitment Details Original Study CA139-540 (NCT 00344552) at Dr. K. Kato National Cancer Center Hospital in Tokyo, Japan, closed in 2008 and one participant rolled over into Study CA139-557.
Pre-assignment Details To be enrolled in Study CA139-557, participants with advanced or recurrent esophageal cancer must have completed original Study CA139-540 (NCT 00344552) and investigator(s) deemed that continuing treatment with paclitaxel would benefit the participant.
Arm/Group Title Paclitaxel
Hide Arm/Group Description Paclitaxel dosed at the same dose level as last dose received in original study (100 mg/m^2, 80 mg/m^2, or 60 mg/m^2) and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consisted of 49 days total.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Paclitaxel
Hide Arm/Group Description Paclitaxel dosed at the same dose level as last dose received in original Study CA139-540 (NCT 00344552)and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest. One treatment course consisted of 49 days total.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
47 [1]   (NA)
[1]
Only one participant, therefore no standard deviation available.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 1 participants
1
1.Primary Outcome
Title Number of Adverse Events (AEs) Per Participant
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Severity of the adverse event was judged and graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0.
Time Frame Weekly Day 1 to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only one participant enrolled in the study so all results represent one participant.
Arm/Group Title Paclitaxel
Hide Arm/Group Description:
Paclitaxel dosed weekly (6 weeks on, 1 week off).
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: adverse events
32
2.Secondary Outcome
Title Number of Participants With Complete Response to Tumor
Hide Description Tumor measured/evaluated via imaging and assessed according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.0 wherein complete response is disappearance of all target lesions; partial response is 30% decrease in the sum of the longest diameter of target lesions; progressive disease is 20% increase in the sum of the longest diameter of target lesions, and stable disease is small changes that do not meet above criteria. The baseline assessment was done prior to the first administration of drug in the original Study CA139-540 (NCT 00344552).
Time Frame Every 7 weeks Day 1 to 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only one participant enrolled so results are for one participant.
Arm/Group Title Paclitaxel
Hide Arm/Group Description:
Paclitaxel dosed weekly (6 weeks on, 1 week off).
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
1
Time Frame 4 years (4 March 2008 to 24 March 2012)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paclitaxel
Hide Arm/Group Description Paclitaxel dosed weekly (6 weeks on, 1 week off).
All-Cause Mortality
Paclitaxel
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Paclitaxel
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Paclitaxel
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Gastrointestinal disorders   
dysphagia * 1 [1]  1/1 (100.00%)  2
gingivitis * 1 [2]  1/1 (100.00%)  3
Nausea * 1 [1]  1/1 (100.00%)  2
periodontitis * 1 [3]  1/1 (100.00%)  1
General disorders   
chills * 1 [3]  1/1 (100.00%)  1
fatigue * 1 [1]  1/1 (100.00%)  2
malaise * 1 [4]  1/1 (100.00%)  6
edema * 1 [5]  1/1 (100.00%)  28
pyrexia * 1 [1]  1/1 (100.00%)  3
Infections and infestations   
cystitis * 1 [6]  1/1 (100.00%)  2
herpes zoster * 1 [7]  1/1 (100.00%)  2
nasopharyngitis * 1 [8]  1/1 (100.00%)  7
pharyngitis * 1 [9]  1/1 (100.00%)  1
Injury, poisoning and procedural complications   
contusion * 1 [1]  1/1 (100.00%)  2
Investigations   
neutrophil count decrease * 1 [10]  1/1 (100.00%)  44
blood pressure increased * 1 [11]  1/1 (100.00%)  1
glucose urine present * 1 [12]  1/1 (100.00%)  2
hemoglobin decreased * 1 [13]  1/1 (100.00%)  31
protein urine present * 1 [7]  1/1 (100.00%)  2
weight decreased * 1 [1]  1/1 (100.00%)  5
white blood cell count decreased * 1 [14]  1/1 (100.00%)  42
Metabolism and nutrition disorders   
decreased appetite * 1 [1]  1/1 (100.00%)  2
Musculoskeletal and connective tissue disorders   
back pain * 1 [15]  1/1 (100.00%)  13
muscle spasm * 1 [1]  1/1 (100.00%)  12
Nervous system disorders   
dizziness * 1 [1]  1/1 (100.00%)  11
dysgeusia * 1 [9]  1/1 (100.00%)  1
hypoesthesia * 1 [16]  1/1 (100.00%)  30
peripheral motor neuropathy * 1 [1]  1/1 (100.00%)  4
Respiratory, thoracic and mediastinal disorders   
cough * 1 [1]  1/1 (100.00%)  2
Skin and subcutaneous tissue disorders   
alopecia * 1 [17]  1/1 (100.00%)  30
dry skin * 1 [1]  1/1 (100.00%)  3
eczema * 1 [3]  1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI-CTC version 2.0
[1]
Grade 1 events
[2]
one Grade 1 event; two Grade 2 events
[3]
Grade 1 event
[4]
Five were Grade 1 events; one event was Grade 2
[5]
19 Grade 1 events; 9 Grade 2 events
[6]
one event Grade 1; one event Grade 2
[7]
One Grade 1 event; one Grade 2 event
[8]
Five events were Grade 1; 2 events were Grade 2
[9]
Grade 2 event
[10]
16 events were Grade 1, 26 events were Grade 2 and 2 events were Grade 3
[11]
1 event Grade 1
[12]
Grade 2 events
[13]
One event Grade 1; 30 events Grade 2
[14]
11 Grade 1 events; 31 Grade 2 events
[15]
11 events were Grade 1; 2 events were Grade 2
[16]
29 Grade 1 events; 1 Grade 2 event
[17]
29 events were Grade 1; 1 event was Grade 2
Upon completion of Study CA139-540 (NCT 00344552), one subject (who had received 7 courses paclitaxel) rolled over into Study CA139-557. During four years in Study CA139-557, subject received an additional 30 courses of paclitaxel.
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00971841     History of Changes
Other Study ID Numbers: CA139-557
First Submitted: September 3, 2009
First Posted: September 4, 2009
Results First Submitted: May 24, 2013
Results First Posted: July 19, 2013
Last Update Posted: July 26, 2013