Trial Outcomes & Findings for Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer (NCT NCT00883675)

NCT ID: NCT00883675

Last Updated: 2013-12-18

Results Overview

The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of \<10%.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 133 participants
• Primary outcome timeframe: 2 months
• Results posted on: 2013-12-18

Participant Flow

Enrollment of patients took place at a single center in the United States (Dartmouth-Hitchcock Norris Cotton Cancer Center) and at ten sites in China that were early members of the China Clinical Trials Consortium.

Participant milestones

Measure	Treatment Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
Overall Study STARTED	133
Overall Study COMPLETED	133
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer

Baseline characteristics by cohort

Measure	Treatment n=133 Participants Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	87 Participants n=93 Participants
Age, Categorical >=65 years	46 Participants n=93 Participants
Age Continuous	59.8 years STANDARD_DEVIATION 9.3 • n=93 Participants
Sex: Female, Male Female	44 Participants n=93 Participants
Sex: Female, Male Male	89 Participants n=93 Participants
Region of Enrollment United States	2 participants n=93 Participants
Region of Enrollment China	131 participants n=93 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Intent to treat

The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%.

Outcome measures

Measure	Treatment n=133 Participants Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
Febrile Neutropenia	12 participants

Adverse Events

Treatment

Serious events: 14 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=133 participants at risk Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
Immune system disorders Allergic Reaction	3.0% 4/133 • Number of events 4
Blood and lymphatic system disorders Febrile Neutropenia	0.75% 1/133 • Number of events 1
Blood and lymphatic system disorders Infection	2.3% 3/133 • Number of events 3
Blood and lymphatic system disorders Severe Neutropenia	2.3% 3/133 • Number of events 4
Gastrointestinal disorders Severe Nausea and Vomiting	1.5% 2/133 • Number of events 4
Infections and infestations Pelvic Infection	0.75% 1/133 • Number of events 1

Other adverse events

Measure	Treatment n=133 participants at risk Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
Infections and infestations Febrile Neutropenia	8.3% 11/133 • Number of events 11
Blood and lymphatic system disorders Neutropenia	41.4% 55/133 • Number of events 55

Additional Information

Michael Mann, MD

Maestro

Phone: 650-380-9579

Email: michael.mann@ucsfmedctr.org

Results disclosure agreements

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

Restriction type: GT60