Trial Outcomes & Findings for Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer (NCT NCT00301808)
NCT ID: NCT00301808
Last Updated: 2023-05-06
Results Overview
Overall Survival at one year using Kaplan-Meier product-limit analysis
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
at 1 year
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
Cisplatin, Docetaxel & Radiation Therapy
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Cisplatin, Docetaxel & Radiation Therapy
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
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|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Death
|
3
|
|
Overall Study
Lack of Efficacy
|
4
|
Baseline Characteristics
Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cisplatin, Docetaxel & Radiation Therapy
n=29 Participants
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
|
|---|---|
|
Age, Continuous
|
60.76 years
STANDARD_DEVIATION 8.03 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 1 yearOverall Survival at one year using Kaplan-Meier product-limit analysis
Outcome measures
| Measure |
Cisplatin, Docetaxel & Radiation Therapy
n=29 Participants
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
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|---|---|
|
Probability of Overall Survival at One Year
|
0.66 probability of overall survival at 1 yr.
Interval 0.48 to 0.84
|
SECONDARY outcome
Timeframe: Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.Progression-free survival using Kaplan-Meier estimates
Outcome measures
| Measure |
Cisplatin, Docetaxel & Radiation Therapy
n=29 Participants
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
|
|---|---|
|
Progression-free Survival
|
16.9 months
Interval 7.2 to 36.2
|
SECONDARY outcome
Timeframe: Date of registration to the date of deathOverall survival using Kaplan-Meier estimates
Outcome measures
| Measure |
Cisplatin, Docetaxel & Radiation Therapy
n=29 Participants
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
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|---|---|
|
Overall Survival
|
33.7 months
Interval 6.4 to
All observations after the median was reached are censored.
|
SECONDARY outcome
Timeframe: 72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a yearToxicity: total number of SAEs and other AEs
Outcome measures
| Measure |
Cisplatin, Docetaxel & Radiation Therapy
n=29 Participants
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
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|---|---|
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Safety Outcomes
Serious (grade 3 or 4)
|
20 Adverse event
|
|
Safety Outcomes
other (grade 0, 1, or 2)
|
245 Adverse event
|
Adverse Events
Cisplatin, Docetaxel & Radiation Therapy
Serious events: 15 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cisplatin, Docetaxel & Radiation Therapy
n=29 participants at risk
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
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|---|---|
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Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
1/29 • Number of events 1 • Approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
6.9%
2/29 • Number of events 2 • Approximately 7 years
|
|
General disorders
Fever
|
6.9%
2/29 • Number of events 2 • Approximately 7 years
|
|
Renal and urinary disorders
Acute renal failure
|
10.3%
3/29 • Number of events 3 • Approximately 7 years
|
|
Vascular disorders
Hypotension
|
3.4%
1/29 • Number of events 1 • Approximately 7 years
|
|
Nervous system disorders
Headache
|
3.4%
1/29 • Number of events 1 • Approximately 7 years
|
|
Nervous system disorders
Stroke
|
3.4%
1/29 • Number of events 1 • Approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.9%
2/29 • Number of events 2 • Approximately 7 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
1/29 • Number of events 1 • Approximately 7 years
|
|
Gastrointestinal disorders
Esophagitis
|
6.9%
2/29 • Number of events 2 • Approximately 7 years
|
|
Infections and infestations
Pharyngitis
|
3.4%
1/29 • Number of events 1 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.4%
1/29 • Number of events 1 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
1/29 • Number of events 1 • Approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary exacerbation
|
3.4%
1/29 • Number of events 1 • Approximately 7 years
|
Other adverse events
| Measure |
Cisplatin, Docetaxel & Radiation Therapy
n=29 participants at risk
Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle
Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
|
|---|---|
|
Gastrointestinal disorders
Esophagitis
|
69.0%
20/29 • Number of events 20 • Approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
13.8%
4/29 • Number of events 4 • Approximately 7 years
|
|
Investigations
Decreased WBC count
|
75.9%
22/29 • Number of events 22 • Approximately 7 years
|
|
Blood and lymphatic system disorders
Anemia
|
75.9%
22/29 • Number of events 22 • Approximately 7 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
58.6%
17/29 • Number of events 17 • Approximately 7 years
|
|
Investigations
Platelet count decreased
|
58.6%
17/29 • Number of events 17 • Approximately 7 years
|
|
General disorders
Fatigue
|
69.0%
20/29 • Number of events 20 • Approximately 7 years
|
|
General disorders
Fever
|
13.8%
4/29 • Number of events 4 • Approximately 7 years
|
|
Gastrointestinal disorders
Constipation
|
24.1%
7/29 • Number of events 7 • Approximately 7 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.7%
6/29 • Number of events 6 • Approximately 7 years
|
|
Gastrointestinal disorders
Nausea
|
44.8%
13/29 • Number of events 13 • Approximately 7 years
|
|
Gastrointestinal disorders
Vomiting
|
37.9%
11/29 • Number of events 11 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Anorexia
|
48.3%
14/29 • Number of events 14 • Approximately 7 years
|
|
Gastrointestinal disorders
Stomatitis
|
6.9%
2/29 • Number of events 2 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
86.2%
25/29 • Number of events 25 • Approximately 7 years
|
|
Investigations
Aspartate aminotransferase increased
|
10.3%
3/29 • Number of events 3 • Approximately 7 years
|
|
Investigations
Alkaline phosphatase increased
|
6.9%
2/29 • Number of events 2 • Approximately 7 years
|
|
Investigations
Alanine Aminotransferase (ALT)
|
10.3%
3/29 • Number of events 3 • Approximately 7 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.7%
6/29 • Number of events 6 • Approximately 7 years
|
|
Investigations
Creatinine increased
|
20.7%
6/29 • Number of events 6 • Approximately 7 years
|
|
Infections and infestations
Infection
|
20.7%
6/29 • Number of events 6 • Approximately 7 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.8%
4/29 • Number of events 4 • Approximately 7 years
|
|
General disorders
Pain
|
20.7%
6/29 • Number of events 6 • Approximately 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.2%
5/29 • Number of events 5 • Approximately 7 years
|
Additional Information
Shrish Gadgeel, M.D.
Barbara Ann Karmanos Cancer Institute
Phone: (313) 556-8820
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place