Phase I Study of Oxaliplatin in Combination With Docetaxel and Radiotherapy in Patients With Unresectable or Recurrent Non-Small Cell Lung Cancer (NSCLC)
- Determine the maximum tolerated dose of oxaliplatin when given with docetaxel and
thoracic radiotherapy in patients with unresectable stage II, IIIA, or IIIB or
recurrent non-small cell lung cancer.
- Determine the dose-limiting toxicities of this regimen in these patients.
- Determine the objective tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of oxaliplatin.
- Induction therapy: Patients undergo radiotherapy once a day on days 1-5, 8-12, 15-19,
22-26, 29-33, 36-40, and 43-47. Patients also receive docetaxel intravenous (IV) over 1
hour on days 1, 8, 15, 22, 29, 36, and 43 and oxaliplatin IV over 2-4 hours on days 2,
9, 16, 23, 30, 37, and 44. Patients with stable or responding disease proceed to
Cohorts of 6 patients receive escalating doses of oxaliplatin during induction therapy until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 3 of 6 patients experience dose-limiting toxicity.
- Consolidation therapy: Beginning 3 weeks after the completion of induction therapy,
patients receive consolidation therapy comprising docetaxel IV over 1 hour immediately
followed by oxaliplatin IV over 2-4 hours on day 1. Treatment repeats every 21 days for
2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3
months for up to 2 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy
Within 90 days of radiotherapy
L. Chinsoo Cho, MD
University of Minnesota - Clinical and Translational Science Institute
United States: Food and Drug Administration
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|