Non-small Cell Lung Cancer
Conditions
Keywords
Lung cancer, Adjuvant therapy
Brief summary
The purpose of this study is to determine whether it is safe to treat lung cancer patients who have undergone an attempt at curative resection with the combination of docetaxel and carboplatin.
Detailed description
Patients with stage Ib - IIIa NSCLC participated in an open-label, single arm study to assess the safety and tolerability of docetaxel (75 mg/kg) and carboplatin (AUC 5.5) administered for 3 cycles after resection for curative intent. The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of \<10%. Other endpoints assessed protocol compliance and the impact of minimally invasive surgical technique.
Interventions
DRUGDocetaxel-Carboplatin
Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin AUC 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
Sponsors
Sanofi
Michael Mann
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-small cell lung cancer stage IB - IIIA, complete resection with mediastinal lymph node dissection * ECOG status 0-1 * \>14 and \<56 days since resection
Exclusion criteria
* Prior chemotherapy and/or radiation therapy for lung cancer * Peripheral neuropathy \> grade 1 * Concurrent other malignancies, other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * Medical condition that will not permit treatment or follow up according to the protocol * Prior treatment with docetaxel or carboplatin * Hypersensitivity to polysorbate 80, platinum-containing compounds or mannitol * Treatment with other investigational anti-cancer drugs within 30 days of registration * Pregnant or nursing women * HIV-positive patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Febrile Neutropenia | 2 months | The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of \<10%. |
Countries
China, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment 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 | 133 |
| Total | 133 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 46 Participants |
| Age, Categorical Between 18 and 65 years | 87 Participants |
| Age Continuous | 59.8 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment China | 131 participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 66 / 133 |
| serious Total, serious adverse events | 14 / 133 |
Outcome results
Primary
Febrile Neutropenia
The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of \<10%.
Time frame: 2 months
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Febrile Neutropenia | 12 participants |