Trial Outcomes & Findings for Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma (NCT NCT00010257)
NCT ID: NCT00010257
Last Updated: 2023-06-29
Results Overview
Number of eligible, treated participants in each response category by RECIST criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Assessed every 2 cycles (6 weeks)
Results posted on
2023-06-29
Participant Flow
The study was activated on February 21, 2001 and accrued its first patient on June 19, 2001. The thymoma stratum closed to accrual on March 27, 2007. The thymic carcinoma stratum closed to accrual on January 18, 2008.
Participant milestones
| Measure |
Thymoma
Patients with diagnosis of thymoma
|
Thymic Carcinoma
Patients with diagnosis of thymic carcinoma
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
21
|
|
Overall Study
COMPLETED
|
24
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Thymoma
Patients with diagnosis of thymoma
|
Thymic Carcinoma
Patients with diagnosis of thymic carcinoma
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma
Baseline characteristics by cohort
| Measure |
Thymoma
n=25 Participants
Patients with diagnosis of thymoma
|
Thymic Carcinoma
n=21 Participants
Patients with diagnosis of thymic carcinoma
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.8 Years
n=5 Participants
|
49.2 Years
n=7 Participants
|
50.7 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
21 participants
n=7 Participants
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed every 2 cycles (6 weeks)Population: Analysis population included all eligible participants who received at least 1 dose of the protocol treatment
Number of eligible, treated participants in each response category by RECIST criteria
Outcome measures
| Measure |
Thymoma
n=23 Participants
Patients with diagnosis of thymoma
|
Thymic Carcinoma
n=20 Participants
Patients with diagnosis of thymic carcinoma
|
|---|---|---|
|
Best Overall Response by RECIST Criteria (Version 1.0)
Complete Response
|
3 Participants
|
0 Participants
|
|
Best Overall Response by RECIST Criteria (Version 1.0)
Partial Response
|
5 Participants
|
6 Participants
|
|
Best Overall Response by RECIST Criteria (Version 1.0)
Stable Disease
|
13 Participants
|
8 Participants
|
|
Best Overall Response by RECIST Criteria (Version 1.0)
Progression
|
0 Participants
|
4 Participants
|
|
Best Overall Response by RECIST Criteria (Version 1.0)
Unevaluable
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafterPopulation: Number of participants achieving a complete or partial response by RECIST criteria
Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria
Outcome measures
| Measure |
Thymoma
n=8 Participants
Patients with diagnosis of thymoma
|
Thymic Carcinoma
n=6 Participants
Patients with diagnosis of thymic carcinoma
|
|---|---|---|
|
Duration of Response
|
16.9 Months
Interval 14.0 to
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.
|
5.0 Months
Interval 3.1 to 9.9
|
Adverse Events
Thymoma
Serious events: 13 serious events
Other events: 24 other events
Deaths: 0 deaths
Thymic Carcinoma
Serious events: 14 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Thymoma
n=24 participants at risk
Patients with diagnosis of thymoma
|
Thymic Carcinoma
n=21 participants at risk
Patients with diagnosis of thymic carcinoma
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
1/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
3/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
23.8%
5/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
8/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
28.6%
6/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.2%
1/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
4.8%
1/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Cardiac, Other
|
4.2%
1/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
0.00%
0/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
8.3%
2/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
28.6%
6/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
4.2%
1/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
0.00%
0/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
4.8%
1/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
0.00%
0/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
4.8%
1/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
4.8%
1/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Febrile Neutropenia
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection with grade 3-4 neutropenia
|
4.2%
1/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
4.8%
1/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.2%
1/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
0.00%
0/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy - Sensory
|
16.7%
4/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
0.00%
0/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
2/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
0.00%
0/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
4.8%
1/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
Other adverse events
| Measure |
Thymoma
n=24 participants at risk
Patients with diagnosis of thymoma
|
Thymic Carcinoma
n=21 participants at risk
Patients with diagnosis of thymic carcinoma
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
70.8%
17/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
90.5%
19/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
4.8%
1/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
54.2%
13/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
57.1%
12/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
62.5%
15/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
47.6%
10/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.8%
5/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
42.9%
9/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Edema
|
8.3%
2/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Hypotension
|
8.3%
2/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
0.00%
0/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
79.2%
19/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
76.2%
16/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fever
|
8.3%
2/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
14.3%
3/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Rigors/Chills
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
4.2%
1/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Weight Gain
|
4.2%
1/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
91.7%
22/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
81.0%
17/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
8.3%
2/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
0.00%
0/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Pigmentation
|
8.3%
2/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
0.00%
0/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
3/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
14.3%
3/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
25.0%
6/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
19.0%
4/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
8/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
42.9%
9/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
3/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
14.3%
3/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
54.2%
13/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
81.0%
17/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
3/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
33.3%
7/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Taste Disturbance
|
12.5%
3/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
9/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
57.1%
12/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea w/o Prior Colostomy
|
20.8%
5/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
52.4%
11/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
14.3%
3/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Alkaline Phosphatase Increased
|
4.2%
1/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
33.3%
7/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Bilirubin Increased
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Investigations
AST Increased
|
20.8%
5/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
28.6%
6/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Investigations
ALT Increased
|
16.7%
4/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
23.8%
5/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Ataxia
|
8.3%
2/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
4.8%
1/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Dizziness/Lightheadedness
|
12.5%
3/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Insomnia
|
16.7%
4/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
14.3%
3/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Memory Loss
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Anxiety/Agitation
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
14.3%
3/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy - Motor
|
12.5%
3/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
28.6%
6/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy - Sensory
|
95.8%
23/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
76.2%
16/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.2%
1/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
14.3%
3/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
62.5%
15/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
38.1%
8/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
14.3%
3/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
58.3%
14/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
47.6%
10/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
14.3%
3/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
6/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
28.6%
6/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Creatinine Increased
|
8.3%
2/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
14.3%
3/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
|
Renal and urinary disorders
Urinary Frequency/Urgency
|
0.00%
0/24 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
9.5%
2/21 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place