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Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00004859
Recruitment Status : Terminated (Trial was stopped early for futility)
First Posted : January 27, 2003
Results First Posted : March 22, 2012
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: carboplatin
Drug: paclitaxel
Drug: thalidomide
Radiation: radiation therapy
Enrollment 589
Recruitment Details The study was activated on January 27, 2000, and was terminated on October 26, 2006. 589 patients were enrolled to the study.
Pre-assignment Details  
Arm/Group Title Arm A (Paclitaxel + Carboplatin + Radiation ) Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Hide Arm/Group Description Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.

Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.

Paclitaxel, carboplatin and radiation same as active comparator.

Period Title: Overall Study
Started 295 294
Eligible 275 271
Treated 289 289
Treated and Having Toxicity Data 289 288 [1]
Completed 177 12
Not Completed 118 282
Reason Not Completed
Lack of Efficacy             43             113
Adverse Event             31             93
Death             5             5
Withdrawal by Subject             7             33
Protocol Violation             2             2
other disease             0             3
error             3             1
missing data             14             11
Not specified             13             21
[1]
1 patient had missing record for toxicity
Arm/Group Title Arm A (Paclitaxel + Carboplatin + Radiation ) Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) Total
Hide Arm/Group Description Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.

Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.

Paclitaxel, carboplatin and radiation same as active comparator.

Total of all reporting groups
Overall Number of Baseline Participants 275 271 546
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 275 participants 271 participants 546 participants
62.9  (9.0) 62.2  (10.5) 62.6  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 275 participants 271 participants 546 participants
Female
104
  37.8%
108
  39.9%
212
  38.8%
Male
171
  62.2%
163
  60.1%
334
  61.2%
1.Primary Outcome
Title Overall Survival Time
Hide Description Survival time is defined as time from study entry to death from any cause
Time Frame every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat analysis in the 546 eligible patients
Arm/Group Title Arm A (Paclitaxel + Carboplatin + Radiation ) Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Hide Arm/Group Description:
active comparator
experimental arm
Overall Number of Participants Analyzed 275 271
Median (95% Confidence Interval)
Unit of Measure: Months
15.3
(12.4 to 20.6)
16.0
(14.5 to 18.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Paclitaxel + Carboplatin + Radiation ), Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Time to Disease Progression
Hide Description Time to disease progression is defined as the time from randomization to documented disease progression or to death without progression. Patients without documented progression or death reported were censored at the time of the last documented disease evaluation. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
Time Frame every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Paclitaxel + Carboplatin + Radiation ) Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Hide Arm/Group Description:
active comparator
experimental arm
Overall Number of Participants Analyzed 275 271
Median (95% Confidence Interval)
Unit of Measure: Months
7.4
(6.6 to 8.6)
7.8
(6.9 to 8.8)
3.Secondary Outcome
Title Response Rate at Best Response to Treatment
Hide Description Proportion of patients with complete or partial response using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Complete response is defined as the complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response is defined as greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease.
Time Frame every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Paclitaxel + Carboplatin + Radiation ) Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Hide Arm/Group Description:
Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.

Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.

Paclitaxel, carboplatin and radiation same as active comparator.

Overall Number of Participants Analyzed 275 271
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.35
(0.29 to 0.41)
0.38
(0.32 to 0.44)
Time Frame Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A (Paclitaxel + Carboplatin + Radiation ) Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Hide Arm/Group Description Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.

Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.

Paclitaxel, carboplatin and radiation same as active comparator.

All-Cause Mortality
Arm A (Paclitaxel + Carboplatin + Radiation ) Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A (Paclitaxel + Carboplatin + Radiation ) Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Affected / at Risk (%) Affected / at Risk (%)
Total   222/289 (76.82%)   249/288 (86.46%) 
Blood and lymphatic system disorders     
Anemia  1  8/289 (2.77%)  4/288 (1.39%) 
Transfusion: platelets  1  1/289 (0.35%)  0/288 (0.00%) 
Transfusion:pRBCs  1  15/289 (5.19%)  6/288 (2.08%) 
Febrile neutropenia  1  8/289 (2.77%)  7/288 (2.43%) 
Cardiac disorders     
Sinus bradycardia  1  0/289 (0.00%)  2/288 (0.69%) 
Sinus tachycardia  1  1/289 (0.35%)  1/288 (0.35%) 
Supraventricular arrhythmias  1  2/289 (0.69%)  6/288 (2.08%) 
Ventricular function  1  2/289 (0.69%)  1/288 (0.35%) 
Pericardial effusion/pericarditis  1  1/289 (0.35%)  1/288 (0.35%) 
Cardiac-other  1  1/289 (0.35%)  0/288 (0.00%) 
Chest pain  1  2/289 (0.69%)  2/288 (0.69%) 
Ear and labyrinth disorders     
Inner ear/hearing imparied  1  1/289 (0.35%)  0/288 (0.00%) 
Hearing-other  1  1/289 (0.35%)  0/288 (0.00%) 
Vertigo  1  1/289 (0.35%)  2/288 (0.69%) 
Earache  1  0/289 (0.00%)  1/288 (0.35%) 
Eye disorders     
Ocular-other  1  0/289 (0.00%)  1/288 (0.35%) 
Gastrointestinal disorders     
Constipation  1  4/289 (1.38%)  26/288 (9.03%) 
Dyspepsia  1  3/289 (1.04%)  0/288 (0.00%) 
Dysphagia  1  1/289 (0.35%)  2/288 (0.69%) 
Fistula-intestinal  1  1/289 (0.35%)  0/288 (0.00%) 
Ileus  1  0/289 (0.00%)  2/288 (0.69%) 
Nausea  1  17/289 (5.88%)  14/288 (4.86%) 
Stomatitis  1  8/289 (2.77%)  7/288 (2.43%) 
Taste disturbance  1  0/289 (0.00%)  1/288 (0.35%) 
Vomiting  1  14/289 (4.84%)  7/288 (2.43%) 
Diarrhea w/o prior colostomy  1  5/289 (1.73%)  8/288 (2.78%) 
GI-other  1  0/289 (0.00%)  1/288 (0.35%) 
Melena/GI bleeding  1  0/289 (0.00%)  1/288 (0.35%) 
Abonominal pain  1  0/289 (0.00%)  1/288 (0.35%) 
General disorders     
Edema  1  1/289 (0.35%)  8/288 (2.78%) 
Fatigue  1  16/289 (5.54%)  42/288 (14.58%) 
Fever  1  1/289 (0.35%)  1/288 (0.35%) 
Injection site reaction  1  0/289 (0.00%)  1/288 (0.35%) 
Pain-other  1  1/289 (0.35%)  1/288 (0.35%) 
Immune system disorders     
Allergic reaction  1  16/289 (5.54%)  13/288 (4.51%) 
Infections and infestations     
Infection w/ grade 3 or 4 neutropenia  1  9/289 (3.11%)  15/288 (5.21%) 
Infection w/ unknown ANC  1  1/289 (0.35%)  3/288 (1.04%) 
Infection w/o neutropenia  1  5/289 (1.73%)  5/288 (1.74%) 
Injury, poisoning and procedural complications     
Radiation dermatitis  1  3/289 (1.04%)  2/288 (0.69%) 
Wound -infectious  1  0/289 (0.00%)  1/288 (0.35%) 
Wound -non infectious  1  1/289 (0.35%)  0/288 (0.00%) 
Dysphagia-esophageal radiation  1  4/289 (1.38%)  3/288 (1.04%) 
Mucositis due to radiation  1  1/289 (0.35%)  0/288 (0.00%) 
Pain due to radiation  1  2/289 (0.69%)  2/288 (0.69%) 
Investigations     
Leukopenia  1  69/289 (23.88%)  81/288 (28.13%) 
Lymphopenia  1  2/289 (0.69%)  2/288 (0.69%) 
Neutropenia  1  146/289 (50.52%)  161/288 (55.90%) 
Thrombocytopenia  1  10/289 (3.46%)  6/288 (2.08%) 
Weight gain  1  0/289 (0.00%)  1/288 (0.35%) 
Weight loss  1  2/289 (0.69%)  5/288 (1.74%) 
Elevated Partial Thromboplastin Time (PTT)  1  1/289 (0.35%)  0/288 (0.00%) 
Elevated Prothrombin Time (PT)  1  0/289 (0.00%)  1/288 (0.35%) 
Bilirubin increased  1  0/289 (0.00%)  1/288 (0.35%) 
AST increased  1  1/289 (0.35%)  0/288 (0.00%) 
ALT increased  1  1/289 (0.35%)  0/288 (0.00%) 
Creatinine increased  1  0/289 (0.00%)  1/288 (0.35%) 
Metabolism and nutrition disorders     
Anorexia  1  10/289 (3.46%)  12/288 (4.17%) 
Dehydration  1  10/289 (3.46%)  6/288 (2.08%) 
Hypercalcemia  1  0/289 (0.00%)  2/288 (0.69%) 
Hyperglycemia  1  8/289 (2.77%)  4/288 (1.39%) 
Hyperkalemia  1  1/289 (0.35%)  1/288 (0.35%) 
Hypokalemia  1  3/289 (1.04%)  11/288 (3.82%) 
Hyponatremia  1  14/289 (4.84%)  15/288 (5.21%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness  1  2/289 (0.69%)  3/288 (1.04%) 
Myositis  1  0/289 (0.00%)  1/288 (0.35%) 
Joint,muscle, bone-other  1  0/289 (0.00%)  1/288 (0.35%) 
Arthralgia  1  8/289 (2.77%)  14/288 (4.86%) 
Bone pain  1  0/289 (0.00%)  3/288 (1.04%) 
Myalgia  1  7/289 (2.42%)  14/288 (4.86%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1  0/289 (0.00%)  1/288 (0.35%) 
Nervous system disorders     
Vasovagal episode  1  1/289 (0.35%)  0/288 (0.00%) 
Cognitive disturbance  1  0/289 (0.00%)  1/288 (0.35%) 
Depressed level of consciousness  1  1/289 (0.35%)  15/288 (5.21%) 
Memory loss  1  0/289 (0.00%)  2/288 (0.69%) 
Neuropathy-motor  1  5/289 (1.73%)  9/288 (3.13%) 
Neuropathy-sensory  1  16/289 (5.54%)  33/288 (11.46%) 
Seizure  1  0/289 (0.00%)  1/288 (0.35%) 
Syncope  1  4/289 (1.38%)  7/288 (2.43%) 
Tremor  1  0/289 (0.00%)  5/288 (1.74%) 
Neuropathic pain  1  2/289 (0.69%)  0/288 (0.00%) 
Psychiatric disorders     
Confusion  1  0/289 (0.00%)  2/288 (0.69%) 
Dizziness/lightheadedness  1  1/289 (0.35%)  14/288 (4.86%) 
Hallucinations  1  0/289 (0.00%)  2/288 (0.69%) 
Insomnia  1  1/289 (0.35%)  0/288 (0.00%) 
Depression  1  1/289 (0.35%)  3/288 (1.04%) 
Renal and urinary disorders     
Renal failure  1  1/289 (0.35%)  0/288 (0.00%) 
Reproductive system and breast disorders     
Erectile impotence  1  1/289 (0.35%)  0/288 (0.00%) 
Irregular menses  1  0/289 (0.00%)  1/288 (0.35%) 
Respiratory, thoracic and mediastinal disorders     
Apnea  1  1/289 (0.35%)  1/288 (0.35%) 
Cough  1  2/289 (0.69%)  4/288 (1.39%) 
Dyspnea  1  19/289 (6.57%)  39/288 (13.54%) 
Hiccoughs  1  1/289 (0.35%)  0/288 (0.00%) 
Hypoxia  1  2/289 (0.69%)  9/288 (3.13%) 
Pleural effusion  1  2/289 (0.69%)  3/288 (1.04%) 
Pneumonitis/pulmonary infiltrates  1  8/289 (2.77%)  12/288 (4.17%) 
Pulmonary fibrosis  1  3/289 (1.04%)  0/288 (0.00%) 
Voice changes/dysarthria  1  1/289 (0.35%)  1/288 (0.35%) 
Pulmonary - other  1  1/289 (0.35%)  0/288 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  1/289 (0.35%)  4/288 (1.39%) 
Rash/desquamation  1  4/289 (1.38%)  20/288 (6.94%) 
Urticaria  1  1/289 (0.35%)  1/288 (0.35%) 
Vascular disorders     
Hypertension  1  1/289 (0.35%)  1/288 (0.35%) 
Hypotension  1  3/289 (1.04%)  8/288 (2.78%) 
Peripheral arterial ischemia  1  0/289 (0.00%)  1/288 (0.35%) 
Thrombosis/Embolism  1  6/289 (2.08%)  30/288 (10.42%) 
Visceral arterial ischemia  1  0/289 (0.00%)  1/288 (0.35%) 
Cerebrovascular Ischemia  1  0/289 (0.00%)  2/288 (0.69%) 
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%
Arm A (Paclitaxel + Carboplatin + Radiation ) Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)
Affected / at Risk (%) Affected / at Risk (%)
Total   283/289 (97.92%)   284/288 (98.61%) 
Blood and lymphatic system disorders     
Anemia  1  238/289 (82.35%)  238/288 (82.64%) 
Gastrointestinal disorders     
Constipation  1  85/289 (29.41%)  179/288 (62.15%) 
Dyspepsia  1  22/289 (7.61%)  25/288 (8.68%) 
Dysphagia  1  25/289 (8.65%)  30/288 (10.42%) 
Nausea  1  140/289 (48.44%)  130/288 (45.14%) 
Stomatitis  1  58/289 (20.07%)  68/288 (23.61%) 
Taste disturbance  1  47/289 (16.26%)  54/288 (18.75%) 
Vomiting  1  68/289 (23.53%)  50/288 (17.36%) 
Diarrhea w/o prior colostomy  1  62/289 (21.45%)  40/288 (13.89%) 
General disorders     
Edema  1  24/289 (8.30%)  83/288 (28.82%) 
Fatigue  1  208/289 (71.97%)  223/288 (77.43%) 
Fever  1  20/289 (6.92%)  15/288 (5.21%) 
Pain-other  1  17/289 (5.88%)  14/288 (4.86%) 
Infections and infestations     
Infection w/o neutropenia  1  27/289 (9.34%)  28/288 (9.72%) 
Injury, poisoning and procedural complications     
Radiation dermatitis  1  58/289 (20.07%)  55/288 (19.10%) 
Investigations     
Leukopenia  1  223/289 (77.16%)  229/288 (79.51%) 
Neutropenia  1  187/289 (64.71%)  220/288 (76.39%) 
Thrombocytopenia  1  109/289 (37.72%)  108/288 (37.50%) 
Weight gain  1  4/289 (1.38%)  17/288 (5.90%) 
Weight loss  1  79/289 (27.34%)  64/288 (22.22%) 
Alkaline phosphatase increased  1  62/289 (21.45%)  56/288 (19.44%) 
AST increased  1  34/289 (11.76%)  19/288 (6.60%) 
Creatinine increased  1  27/289 (9.34%)  32/288 (11.11%) 
Metabolism and nutrition disorders     
Anorexia  1  110/289 (38.06%)  97/288 (33.68%) 
Dehydration  1  15/289 (5.19%)  21/288 (7.29%) 
Hyperkalemia  1  20/289 (6.92%)  29/288 (10.07%) 
Hypokalemia  1  34/289 (11.76%)  45/288 (15.63%) 
Hyponatremia  1  91/289 (31.49%)  94/288 (32.64%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  74/289 (25.61%)  93/288 (32.29%) 
Myalgia  1  110/289 (38.06%)  117/288 (40.63%) 
Nervous system disorders     
Depressed level of consciousness  1  4/289 (1.38%)  73/288 (25.35%) 
Dizziness/lightheadedness  1  20/289 (6.92%)  80/288 (27.78%) 
Neuropathy-motor  1  34/289 (11.76%)  60/288 (20.83%) 
Neuropathy-sensory  1  161/289 (55.71%)  206/288 (71.53%) 
Tremor  1  3/289 (1.04%)  31/288 (10.76%) 
Headache  1  28/289 (9.69%)  35/288 (12.15%) 
Psychiatric disorders     
Insomnia  1  18/289 (6.23%)  12/288 (4.17%) 
Anxiety/agitation  1  15/289 (5.19%)  16/288 (5.56%) 
Depression  1  8/289 (2.77%)  18/288 (6.25%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  51/289 (17.65%)  53/288 (18.40%) 
Dyspnea  1  65/289 (22.49%)  99/288 (34.38%) 
Pneumonitis/pulmonary infiltrates  1  21/289 (7.27%)  25/288 (8.68%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  179/289 (61.94%)  176/288 (61.11%) 
Dry skin  1  7/289 (2.42%)  25/288 (8.68%) 
Pruritus  1  21/289 (7.27%)  18/288 (6.25%) 
Rash/desquamation  1  49/289 (16.96%)  89/288 (30.90%) 
Vascular disorders     
Hypotension  1  18/289 (6.23%)  31/288 (10.76%) 
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 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
Name/Title: Study Statistician
Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office
Phone: 617-632-3012
Publications of Results:
Belinsky SA, Grimes M, Johnson D, et al.: Predicting gene promoter methylation in lung tumors through examination of sputum and serum. [Abstract] J Clin Oncol 24 (Suppl 18): A-7208, 416s, 2006.
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004859     History of Changes
Other Study ID Numbers: NCI-2012-02943
U10CA021115 ( U.S. NIH Grant/Contract )
E3598 ( Other Identifier: Eastern Cooperative Oncology Group (ECOG) )
CDR0000067510 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: March 7, 2000
First Posted: January 27, 2003
Results First Submitted: February 16, 2012
Results First Posted: March 22, 2012
Last Update Posted: June 2, 2014