Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC, Chemotherapy induced neutropenia, CIN
Brief summary
TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.
Detailed description
TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel. After randomization, patients in Treatment Arm 1, chemotherapy with carboplatin and docetaxel will be administered on Day 1 of each cycle, followed by Telintra at a starting dose of 3000 mg total daily dose (1500 mg orally, twice daily) on Day 2 until the absolute neutrophil count improves as confirmed by two consecutive measurement at least 24 hours apart. In Treatment Arm 2 (control arm), chemotherapy alone consisting of carboplatin and docetaxel will be administered on Day 1 of each cycle.
Interventions
4500 mg orally per day in two divided doses
Sponsors
Telik
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed NSCLC * Stage IIIb-Stage IV NSCLC * ECOG performance status of 0-2 * Adequate liver and renal function * Adequate bone marrow reserve
Exclusion criteria
* Treatment with neoadjuvant or adjuvant chemotherapy within 1 year * Histologically confirmed mixed tumors containing small cell elements * Treatment with radiotherapy (except limited in nature) within 3 weeks of randomization * History of bone marrow transplantation or stem cell support * Known history of CNS metastasis unless the patient has had treatment with surgery or radiotherapy, is neurologically stable and does not require oral or IV steroids or anticonvulsants * History of HIV * Grade 3 or 4 peripheral neuropathy * Weightloss greater than 5% within 6 months * Uncontrolled pleural effusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of chemotherapy induced neutropenia | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to ANC recovery from ANC nadir | 6 weeks |
| Incidence of febrile neutropenia | 6 weeks |
| Duration of chemotherapy induced severe neutropenia | 6 weeks |
| FACT-N quality of life assessment | 6 weeks |
| safety assessments | 6 weeks |
| Incidence of G-CSF administration | 6 weeks |
Countries
United States
Outcome results
None listed