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

Phase 2

Completed

Interventions: Drug: Cisplatin
Drug: Docetaxel
Drug: Pemetrexed disodium
Radiation: Radiation therapy

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Cisplatin, Docetaxel & Radiation Therapy	Docetaxel	Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin, Docetaxel & Radiation Therapy	Pemetrexed disodium	Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin, Docetaxel & Radiation Therapy	Radiation therapy	Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.
Cisplatin, Docetaxel & Radiation Therapy	Cisplatin	Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.

Primary Outcome Measures

Name	Time	Method
Probability of Overall Survival at One Year	at 1 year	Overall Survival at one year using Kaplan-Meier product-limit analysis

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later.	Progression-free survival using Kaplan-Meier estimates
Overall Survival	Date of registration to the date of death	Overall survival using Kaplan-Meier estimates
Safety Outcomes	72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year	Toxicity: total number of SAEs and other AEs

Locations (2): Veterans Affairs Medical Center - Detroit
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Detroit, Michigan, United States
Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, United States