NCT00301808

Cisplatin, Pemetrexed Disodium, and Radiation Therapy Followed by Docetaxel in Treating Patients With Stage III Non-Small Cell Lung Cancer

Phase II Study of Concurrent Cisplatin/Pemetrexed and RT Followed by Docetaxel in Stage III NSCLC (Non Small Cell Lung Cancer)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, 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. Giving more than one chemotherapy drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium together with radiation therapy followed by docetaxel works in treating patients with stage III non-small cell lung cancer.

Detailed description

OBJECTIVES: Primary * Assess 1-year survival of stage III non-small cell lung cancer (NSCLC) patients treated with cisplatin, pemetrexed disodium, and concurrent thoracic radiotherapy followed by consolidation therapy with docetaxel. Secondary * Assess the progression-free survival and overall survival. * Assess the toxicity of this regimen. OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over 60 minute on day 1. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients also receive concurrent thoracic radiotherapy in weeks 1-7. Between 3-8 weeks after completion of chemoradiotherapy, patients with no progressive disease receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for 3 courses. After completion of study therapy, patients are followed at 1 month and periodically thereafter. PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43
DRUG	Docetaxel	Docetaxel 75 mg/m2 on day 1 of each cycle
DRUG	Pemetrexed disodium	Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43
RADIATION	Radiation therapy	Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.

Timeline

• Start date: 2005-11-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2006-03-13
• Last updated: 2023-05-06
• Results posted: 2014-05-13

Locations

2 sites across 1 country: United States