Non-small Cell Lung Carcinoma
Conditions
Keywords
on-small cell lung carcinoma, chemotherapy naive patient
Brief summary
This is a prospective phase II trial, in patients with unresectable or metastatic NSCLC using chemotherapy regimens which will be defined according to the mRNA expression of ERCC1 and RRM1 of the tumor cells.
Interventions
DRUGchemotherapy
A1: docetaxel 60mg/m2 on Day 1 vinorelbine 20mg/m2 on Day 1 and Day 8 (DV) A2: gemcitabine 1000mg/m2 on Day 1 vinorelbine 25mg/m2 on Day 1 and Day 8 (GV) A3: docetaxel 75mg/m2 on Day 1 carboplatin AUC5 on Day 1 (DC) A4: gemcitabine 1000mg/m2 on Day 1 and 8 carboplatin AUC5 on Day 1 (GC)
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed unresectable advanced or metastatic non-small cell lung cancer (NSCLC) (stage IIIB or IV) 2. Chemotherapy naïve patient (Previous adjuvant or neoadjuvant chemotherapy allowed if the last dose was administered equal to or greater than 6 months ago.) 3. Age \> 18 4. Performance status 0 to 2 by Eastern Cooperative Oncology Group (ECOG) criteria 5. At least one measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) 6. Adequate organ functions (assessed within 14 days of starting treatment) 1) Bone marrow: Absolute neutrophil count ≥ 1,500/mm³, Platelet count ≥ 100,000/mm³, Hemoglobin ≥ 9.0 mg/dL 2) Liver: Total bilirubin ≤ 1.5 x ULN; aspartic transaminase (AST) and alanine transaminase (ALT), alkaline phosphatase(ALP) ≤ 2.5 x ULN 3) Kidney: Serum creatinine ≤ 1.5 x ULN 7. Signed informed consent document
Exclusion criteria
1. Clinically significant serious illness or medical condition (infection) 2. Prior systemic chemotherapy or immunotherapy for advanced NSCLC. 3. Presence of uncontrolled brain or leptomeningeal metastases 4. Prior radiotherapy within 3 weeks of starting treatment 5. Peripheral neuropathy equal to or greater than grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 6. Pregnant or lactating 7. Absolute contraindication of corticosteroid use 8. Patients with a history of severe hypersensitivity reaction to docetaxel, carboplatin, vinorelbine or gemcitabine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall Response Rate | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | ORR was assessed by tumor response evaluation according to RECIST 1.1 at every 8 weeks. Tumor assessments will continue about every 8 weeks until disease progression or initiation of subsequent anticancer treatment. (If PR or CR was first documented, confirmation assessment was done between 4 weeks and 8 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival | up to 4 years |
| overall survival | up to 4 years |
| duration of response | up to 4 years |
| disease control rate | up to 4 years |
Countries
South Korea
Outcome results
None listed