Oxaliplatin, Docetaxel, and Radiation Therapy in Treating Patients With Unresectable Stage II/III or Recurrent NSCLC
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and docetaxel, 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. Oxaliplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving oxaliplatin and docetaxel together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin when given together with docetaxel and radiation therapy in treating patients with unresectable stage II or stage III or recurrent non-small cell lung cancer .
Procedure: radiation therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Oxaliplatin in Combination With Docetaxel and Radiotherapy in Patients With Unresectable or Recurrent Non-Small Cell Lung Cancer (NSCLC)|
- Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy [ Time Frame: Within 90 days of radiotherapy ] [ Designated as safety issue: Yes ]
- Dose-limiting toxicities [ Time Frame: Within 90 days of radiotherapy ] [ Designated as safety issue: Yes ]
- Objective tumor response [ Time Frame: Every 3 months up to 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Experimental: Chemoradiation Treated Patients
Patients receiving Docetaxel, Oxaliplatin and radiotherapy.
60 mg/m2 on day 1 of each week during radiation therapy
Other Name: TaxotereDrug: oxaliplatin
Escalating dose per assignment: 20-50 mg/m2 on day 2 of each week during radiation therapy
Other Name: EloxatinProcedure: radiation therapy
2 Gy Days 1-5 each week, total dose of 70Gy
Other Name: radiotherapy
- 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 consolidation therapy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356941
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|Study Chair:||L. Chinsoo Cho, MD||University of Minnesota - Clinical and Translational Science Institute|