Trial Outcomes & Findings for Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00664105)

NCT ID: NCT00664105

Last Updated: 2012-09-07

Results Overview

Months from on-study to expired/last date known alive.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 63 participants
• Primary outcome timeframe: 14.95 months (average duration, on study date to off-study date)
• Results posted on: 2012-09-07

Participant Flow

Recruitment Period = 2/18/2004 through 1/23/2007

A total of 66 people consented to take part in this study and of those, 1 was determined to be ineligible and 2 withdrew from the study prior to beginning protocol therapy.

Participant milestones

Measure	Chemo-radio Therapy Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
Overall Study STARTED	63
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Measure	Chemo-radio Therapy Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
Overall Study Death	3
Overall Study Withdrawal by Subject	5
Overall Study Adverse Event	9
Overall Study Disease progression	7

Baseline Characteristics

Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Measure	Chemo-radio Therapy n=63 Participants Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants
Age Continuous	63 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants

PRIMARY outcome

Timeframe: 14.95 months (average duration, on study date to off-study date)

Population: Patients who received at least one treatment and who were available for determination of overall survival.

Months from on-study to expired/last date known alive.

Outcome measures

Measure	Chemo-radio Therapy n=63 Participants Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
Overall Survival	11 Months Interval 0.0 to 47.0

SECONDARY outcome

Timeframe: on-study date to date of best response

Population: Patients who were available for measurement of response. Six patients were not available for measurement of response and are not included in the analyzed population

Patient response to treatment per RECIST:

Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD

Outcome measures

Measure	Chemo-radio Therapy n=57 Participants Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
Overall Response Rate Complete Response	6 participants
Overall Response Rate Partial Response	33 participants
Overall Response Rate Progressive Disease	5 participants
Overall Response Rate Stable Disease	13 participants

SECONDARY outcome

Timeframe: on-study date to date of progression

Population: Patients with disease progression.

Time to disease progression in months

Outcome measures

Measure	Chemo-radio Therapy n=39 Participants Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
Time to Disease Progression	5 Months Interval 1.0 to 25.0

SECONDARY outcome

Timeframe: 30 days after last treatment.

Population: Patients who received treatment and who experienced an adverse event.

Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event with 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, and 5 = death related to adverse event

Outcome measures

Measure	Chemo-radio Therapy n=63 Participants Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
Number of Participants With Adverse Events by Grade Grade 1	11 participants
Number of Participants With Adverse Events by Grade Grade 2	19 participants
Number of Participants With Adverse Events by Grade Grade 3	35 participants
Number of Participants With Adverse Events by Grade Grade 4	12 participants
Number of Participants With Adverse Events by Grade Grade 5	3 participants

Adverse Events

Chemo-radio Therapy

Serious events: 37 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Chemo-radio Therapy n=63 participants at risk Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
Metabolism and nutrition disorders Anorexia	3.2% 2/63 • Number of events 2
Surgical and medical procedures Bleeding (associated with surgery)	1.6% 1/63 • Number of events 1
Gastrointestinal disorders Bowel obstruction	1.6% 1/63 • Number of events 1
Skin and subcutaneous tissue disorders Infection Other, Cellulitis	1.6% 1/63 • Number of events 1
Cardiac disorders Chest pain	1.6% 1/63 • Number of events 1
Gastrointestinal disorders Constipation	1.6% 1/63 • Number of events 1
Metabolism and nutrition disorders Dehydration	12.7% 8/63 • Number of events 10
Nervous system disorders Depressed level of consciouness	1.6% 1/63 • Number of events 1
Gastrointestinal disorders Diarrhea	3.2% 2/63 • Number of events 2
Nervous system disorders Dizziness	3.2% 2/63 • Number of events 2
Gastrointestinal disorders Dysphagia - pharynegal (related to radiation)	1.6% 1/63 • Number of events 1
Gastrointestinal disorders Dysphagia, esophagitis, odynophagia	22.2% 14/63 • Number of events 15
Respiratory, thoracic and mediastinal disorders Dyspnea	7.9% 5/63 • Number of events 5
Nervous system disorders Fainting	1.6% 1/63 • Number of events 1
General disorders Fatigue	3.2% 2/63 • Number of events 2
Blood and lymphatic system disorders Febrile neutropenia	4.8% 3/63 • Number of events 3
Investigations Hemoglobin decrease	1.6% 1/63 • Number of events 1
Metabolism and nutrition disorders Hypoglycemia	1.6% 1/63 • Number of events 1
Vascular disorders Hypotension	4.8% 3/63 • Number of events 3
Respiratory, thoracic and mediastinal disorders Hypoxia	6.3% 4/63 • Number of events 4
Blood and lymphatic system disorders Leukocytosis	3.2% 2/63 • Number of events 3
Gastrointestinal disorders Mucositis (due to radiation)	1.6% 1/63 • Number of events 1
Gastrointestinal disorders Nausea	6.3% 4/63 • Number of events 4
Investigations Neutrophil count decrease	3.2% 2/63 • Number of events 2
Surgical and medical procedures Pain due to radiation	1.6% 1/63 • Number of events 1
Infections and infestations Infection other, peg tube abcess	1.6% 1/63 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 1/63 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.2% 2/63 • Number of events 2
Gastrointestinal disorders Rectal bleeding	1.6% 1/63 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.6% 1/63 • Number of events 1
Nervous system disorders Seizure	1.6% 1/63 • Number of events 1
Cardiac disorders Sinus tachycardia	1.6% 1/63 • Number of events 1
Gastrointestinal disorders Stomatitis	3.2% 2/63 • Number of events 2
Cardiac disorders Supraventricular arrhythmias	3.2% 2/63 • Number of events 2
Blood and lymphatic system disorders Transfusion: Packed-Red-Blood-Cells	1.6% 1/63 • Number of events 1
Gastrointestinal disorders Vomiting	1.6% 1/63 • Number of events 1
Investigations Weight loss	9.5% 6/63 • Number of events 6
Musculoskeletal and connective tissue disorders Incomplete fracture of right humerus	1.6% 1/63 • Number of events 1
Cardiac disorders pericardial effusion	1.6% 1/63 • Number of events 1
Cardiac disorders Thrombosis	9.5% 6/63 • Number of events 7
Gastrointestinal disorders Hemorrhage, upper GI bleed	1.6% 1/63 • Number of events 1
Metabolism and nutrition disorders Infection without neutropenia	7.9% 5/63 • Number of events 5
Respiratory, thoracic and mediastinal disorders Hemoptysis	1.6% 1/63 • Number of events 1

Other adverse events

Measure	Chemo-radio Therapy n=63 participants at risk Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.
Blood and lymphatic system disorders Hemoglobin	7.9% 5/63 • Number of events 5
General disorders Fever	4.8% 3/63 • Number of events 4
Musculoskeletal and connective tissue disorders Dehydration	4.8% 3/63 • Number of events 3
Investigations Weight loss	7.9% 5/63 • Number of events 5

Additional Information

Vicki Keedy, M.D.

Vanderbilt-Ingram Cancer Center

Phone: (615) 322-4967

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place