Lung Cancer Clinical Trial
Official title:
A Phase I/II Study of Nab-Paclitaxel and Carboplatin With Concurrent Radiation Therapy for Unresectable Stage III Non-Small-Cell Lung Cancer (NSCLC)
RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Nab-paclitaxel (paclitaxel
albumin-stabilized nanoparticle formulation) may make tumor cells more sensitive to
radiation therapy. Giving nab-paclitaxel together with radiation therapy and carboplatin may
kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving
nab-paclitaxel together with carboplatin and radiation therapy and to see how well it works
in treating patients with stage III non-small-cell lung cancer that cannot be removed by
surgery.
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of nab-paclitaxel when combined concurrently
with carboplatin and radiation followed by two courses of nab-paclitaxel carboplatin as
consolidation. (Phase I)
- To evaluate the progression-free survival in patients with stage III unresectable
non-small cell lung cancer treated with nab-paclitaxel, carboplatin, and radiotherapy
followed by two courses of nab-paclitaxel with carboplatin as consolidation. (Phase II)
Secondary
- To assess safety and tolerability and identify dose-limiting toxicities in patients
receiving nab-paclitaxel combined concurrently with carboplatin and radiotherapy.
(Phase I)
- To assess progression-free survival, response rates, and survival. (Phase I)
- To assess overall survival and response rates in all patients treated on this study.
(Phase II)
- To assess the safety and tolerability of patients receiving nab-paclitaxel combined
concurrently with carboplatin and radiotherapy followed by two courses of
nab-paclitaxel/carboplatin as consolidation. (Phase II) OUTLINE: This is a multicenter
study.
- Phase I:
- Concurrent chemoradiotherapy: Patients receive escalating doses of nab-paclitaxel
IV over 30 minutes and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29,
36, and 43. They also receive conformal radiotherapy once daily 5 days a week on
days 1-5 in weeks 1-7. Patients are evaluated between weeks 8-10. Patients with
disease progression are removed from study. Patients with stable disease, partial
response, or complete response proceed to consolidation chemotherapy 3 weeks after
completion of chemoradiotherapy.
- Consolidation chemotherapy: Patients receive nab-paclitaxel IV over 30 minutes on
days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats
ever 21 days for up to 2 courses.
- Phase II: Patients receive concurrent chemoradiotherapy at the Maximum Tolerated Dose
(MTD) of nab-paclitaxel followed by consolidation chemotherapy as in phase I.
After completion of study treatment, patients are followed at 2 months, every 3 months for 2
years, every 4 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 98 patients (15 patients for phase I and 83 patients for phase
II) will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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