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Trial record 2 of 7 for:    "Thymoma" | "Antineoplastic Agents, Phytogenic"

Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00010257
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : October 18, 2012
Last Update Posted : October 9, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Thymoma
Thymic Carcinoma
Interventions Drug: carboplatin
Drug: paclitaxel
Enrollment 46
Recruitment Details The study was activated on February 21, 2001. The thymoma stratum closed to accrual on March 27, 2007. The thymic carcinoma stratum closed to accrual on January 18, 2008.
Pre-assignment Details  
Arm/Group Title Thymoma Thymic Carcinoma
Hide Arm/Group Description Patients with diagnosis of thymoma Patients with diagnosis of thymic carcinoma
Period Title: Overall Study
Started 25 21
Completed 24 21
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Thymoma Thymic Carcinoma Total
Hide Arm/Group Description Patients with diagnosis of thymoma Patients with diagnosis of thymic carcinoma Total of all reporting groups
Overall Number of Baseline Participants 25 21 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants 21 participants 46 participants
50.8
(32.7 to 76.7)
49.2
(20.8 to 67.1)
50.7
(20.8 to 76.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 21 participants 46 participants
Female
11
  44.0%
6
  28.6%
17
  37.0%
Male
14
  56.0%
15
  71.4%
29
  63.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 21 participants 46 participants
25 21 46
1.Primary Outcome
Title Best Overall Response by RECIST Criteria (Version 1.0)
Hide Description Number of eligible, treated participants in each response category by RECIST criteria
Time Frame Assessed every 2 cycles (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all eligible participants who received at least 1 dose of the protocol treatment
Arm/Group Title Thymoma Thymic Carcinoma
Hide Arm/Group Description:
Patients with diagnosis of thymoma
Patients with diagnosis of thymic carcinoma
Overall Number of Participants Analyzed 23 20
Measure Type: Number
Unit of Measure: Participants
Complete Response 3 0
Partial Response 5 6
Stable Disease 13 8
Progression 0 4
Unevaluable 2 2
2.Secondary Outcome
Title Duration of Response
Hide Description Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria
Time Frame assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants achieving a complete or partial response by RECIST criteria
Arm/Group Title Thymoma Thymic Carcinoma
Hide Arm/Group Description:
Patients with diagnosis of thymoma
Patients with diagnosis of thymic carcinoma
Overall Number of Participants Analyzed 8 6
Median (95% Confidence Interval)
Unit of Measure: Months
16.9 [1] 
(14 to NA)
5.0
(3.1 to 9.9)
[1]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
Time Frame Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Thymoma Thymic Carcinoma
Hide Arm/Group Description Patients with diagnosis of thymoma Patients with diagnosis of thymic carcinoma
All-Cause Mortality
Thymoma Thymic Carcinoma
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Thymoma Thymic Carcinoma
Affected / at Risk (%) Affected / at Risk (%)
Total   13/24 (54.17%)   14/21 (66.67%) 
Blood and lymphatic system disorders     
Anemia  1  1/24 (4.17%)  2/21 (9.52%) 
Leukopenia  1  3/24 (12.50%)  5/21 (23.81%) 
Neutropenia  1  8/24 (33.33%)  6/21 (28.57%) 
Thrombocytopenia  1  1/24 (4.17%)  2/21 (9.52%) 
Cardiac disorders     
Cardiac, Other  1  1/24 (4.17%)  0/21 (0.00%) 
Gastrointestinal disorders     
Nausea  1  1/24 (4.17%)  0/21 (0.00%) 
Vomiting  1  1/24 (4.17%)  1/21 (4.76%) 
Stomatitis  1  0/24 (0.00%)  1/21 (4.76%) 
General disorders     
Fatigue  1  2/24 (8.33%)  6/21 (28.57%) 
Immune system disorders     
Allergic Reaction  1  0/24 (0.00%)  1/21 (4.76%) 
Infections and infestations     
Febrile Neutropenia  1  0/24 (0.00%)  2/21 (9.52%) 
Infection with grade 3-4 neutropenia  1  1/24 (4.17%)  1/21 (4.76%) 
Investigations     
Blood Bilirubin Increased  1  0/24 (0.00%)  2/21 (9.52%) 
Metabolism and nutrition disorders     
Anorexia  1  0/24 (0.00%)  2/21 (9.52%) 
Hyperglycemia  1  1/24 (4.17%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/24 (4.17%)  0/21 (0.00%) 
Myalgia  1  2/24 (8.33%)  0/21 (0.00%) 
Nervous system disorders     
Neuropathy - Sensory  1  4/24 (16.67%)  2/21 (9.52%) 
Seizure  1  0/24 (0.00%)  1/21 (4.76%) 
Skin and subcutaneous tissue disorders     
Rash/desquamation  1  1/24 (4.17%)  0/21 (0.00%) 
Pruritus  1  0/24 (0.00%)  1/21 (4.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Thymoma Thymic Carcinoma
Affected / at Risk (%) Affected / at Risk (%)
Total   24/24 (100.00%)   21/21 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  17/24 (70.83%)  19/21 (90.48%) 
Leukopenia  1  13/24 (54.17%)  12/21 (57.14%) 
Neutropenia  1  15/24 (62.50%)  10/21 (47.62%) 
Thrombocytopenia  1  5/24 (20.83%)  9/21 (42.86%) 
Cardiac disorders     
Chest Pain  1  0/24 (0.00%)  2/21 (9.52%) 
Gastrointestinal disorders     
Constipation  1  3/24 (12.50%)  3/21 (14.29%) 
Nausea  1  13/24 (54.17%)  17/21 (80.95%) 
Stomatitis  1  3/24 (12.50%)  7/21 (33.33%) 
Taste Disturbance  1  3/24 (12.50%)  2/21 (9.52%) 
Vomiting  1  9/24 (37.50%)  12/21 (57.14%) 
Diarrhea w/o Prior Colostomy  1  5/24 (20.83%)  11/21 (52.38%) 
Abdominal Pain  1  1/24 (4.17%)  3/21 (14.29%) 
General disorders     
Edema  1  2/24 (8.33%)  2/21 (9.52%) 
Fatigue  1  19/24 (79.17%)  16/21 (76.19%) 
Fever  1  2/24 (8.33%)  3/21 (14.29%) 
Rigors/Chills  1  0/24 (0.00%)  2/21 (9.52%) 
Immune system disorders     
Allergic Reaction  1  0/24 (0.00%)  1/21 (4.76%) 
Investigations     
Alkaline Phosphatase Increased  1  1/24 (4.17%)  7/21 (33.33%) 
Bilirubin Increased  1  0/24 (0.00%)  2/21 (9.52%) 
AST Increased  1  5/24 (20.83%)  6/21 (28.57%) 
ALT Increased  1  4/24 (16.67%)  5/21 (23.81%) 
Creatinine Increased  1  2/24 (8.33%)  3/21 (14.29%) 
Metabolism and nutrition disorders     
Weight Gain  1  1/24 (4.17%)  2/21 (9.52%) 
Anorexia  1  8/24 (33.33%)  9/21 (42.86%) 
Dehydration  1  0/24 (0.00%)  2/21 (9.52%) 
Musculoskeletal and connective tissue disorders     
Muscle Weakness  1  0/24 (0.00%)  2/21 (9.52%) 
Arthralgia  1  15/24 (62.50%)  8/21 (38.10%) 
Myalgia  1  14/24 (58.33%)  10/21 (47.62%) 
Nervous system disorders     
Ataxia  1  2/24 (8.33%)  1/21 (4.76%) 
Dizziness/Lightheadedness  1  3/24 (12.50%)  2/21 (9.52%) 
Memory Loss  1  0/24 (0.00%)  2/21 (9.52%) 
Neuropathy - Motor  1  3/24 (12.50%)  6/21 (28.57%) 
Neuropathy - Sensory  1  23/24 (95.83%)  16/21 (76.19%) 
Headache  1  3/24 (12.50%)  3/21 (14.29%) 
Psychiatric disorders     
Insomnia  1  4/24 (16.67%)  3/21 (14.29%) 
Anxiety/Agitation  1  0/24 (0.00%)  3/21 (14.29%) 
Renal and urinary disorders     
Urinary Frequency/Urgency  1  0/24 (0.00%)  2/21 (9.52%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  0/24 (0.00%)  3/21 (14.29%) 
Cough  1  2/24 (8.33%)  3/21 (14.29%) 
Dyspnea  1  6/24 (25.00%)  6/21 (28.57%) 
Skin and subcutaneous tissue disorders     
Sweating  1  1/24 (4.17%)  2/21 (9.52%) 
Alopecia  1  22/24 (91.67%)  17/21 (80.95%) 
Nail Changes  1  2/24 (8.33%)  0/21 (0.00%) 
Pigmentation  1  2/24 (8.33%)  0/21 (0.00%) 
Pruritus  1  3/24 (12.50%)  3/21 (14.29%) 
Rash/Desquamation  1  6/24 (25.00%)  4/21 (19.05%) 
Vascular disorders     
Hypotension  1  2/24 (8.33%)  0/21 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Other Publications:
Loehrer PJ, Wang W, Aisner S, et al.: Long-term follow-up of patients with locally advanced or metastatic thymic malignancies: the Eastern Cooperative Oncology Group (ECOG) experience. [Abstract] J Clin Oncol 22 (Suppl 14): A-7050, 629s, 2004.
Layout table for additonal information
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00010257     History of Changes
Other Study ID Numbers: CDR0000068461
U10CA021115 ( U.S. NIH Grant/Contract )
E1C99 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
First Submitted: February 2, 2001
First Posted: January 27, 2003
Results First Submitted: September 17, 2012
Results First Posted: October 18, 2012
Last Update Posted: October 9, 2015