Lung Cancer Clinical Trial
Official title:
A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some
find tumor cells and kill them or carry tumor-killing substances to them. Others interfere
with the ability of tumor cells to grow and spread. Radiation therapy uses high-energy
x-rays to kill tumor cells. Giving docetaxel and cetuximab together with radiation therapy
may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when
given together with cetuximab and radiation therapy in treating patients with stage III
non-small cell lung cancer.
OBJECTIVES:
Primary
- Test the feasibility and toxicity of combined cetuximab, weekly docetaxel, and
concurrent radiotherapy in patients with poor-risk stage III non-small cell lung cancer
(NSCLC).
Secondary
- Evaluate response rates (confirmed and unconfirmed, complete and partial) as well as
overall and progression-free survival.
- Correlate EGFR mutations, KRAS mutations, EGFR/HER2 gene copy number detected by FISH,
and protein expression by immunohistochemistry of EGFR-HER signaling pathways,
phosphorylation, proliferative markers, apoptotic markers, selected oncogene markers,
and markers for angiogenesis in biopsied pre-treatment tumor tissues with response and
survival outcomes.
- Explore possible associations between changes in plasma angiogenic factors (VEGF, IL-8,
bFGF) and cytokine levels (IL-6, IL-1α, ICAM, TGF-β, and others) and the risk of
treatment-related pneumonitis and esophagitis.
OUTLINE: Patients are enrolled sequentially to 1 of 2 treatment groups.
- Cohort 1: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22.
- Cohort 2: Patients receive cetuximab as in group 1 followed by docetaxel IV over 15-30
minutes on days 8, 15, and 22 of course 1 and on days 1, 8, 15, and 22 of course 2.
Initially, 27 patients will be enrolled in Cohort 1. Once all patients in Cohort 1 have
discontinued treatment, if toxicity rates are acceptable per protocol specifications, an
additional 27 patients will be enrolled to Cohort 2. Treatment in both cohorts repeats every
28 days for 2 courses in the absence of disease progression or unacceptable toxicity. All
patients also undergo radiotherapy once daily, 5 days a week, beginning on day 8 of course 1
and continuing through course 2 (approximately 7 weeks). Patients with no progressive
disease then receive cetuximab alone once weekly. Treatment with cetuximab alone continues
in the absence of disease progression for up to 2 years.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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