A Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Docetaxel Consolidation in Patients With Inoperable Squamous Cell Lung Cancer

Study Overview
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Brief Summary
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To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is also planned.

Official Title
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A Phase II Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Every-21-Day Docetaxel Consolidation in Patients With Inoperable Stage IIIA/B Squamous Cell Lung Cancer

Conditions
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Squamous Cell Lung Cancer

Intervention / Treatment
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* Drug: pemetrexed
* Drug: cisplatin
* Radiation: thoracic radiation therapy
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed stage IIIA/ IIIB squamous cell lung cancer; All sites of disease must be amenable to definitive radiotherapy; Age 18 years to 75 years; Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; Forced expiratory volume in 1 second(FEV1)> 0.75L; No previous chest radiotherapy, immunotherapy or biotherapy; Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; Aspartate transaminase(AST) and alanine Transaminase(ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal. For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter; Patients and their family signed the informed consents; Exclusion Criteria: Active infection; History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias); Malnutrition (loss of ≥ 20% of the original body weight); Performance status: 3-4; Sensor or motor neuropathy > grade I; Second primary malignancy, except for non-melanoma skin cancer; Psychiatric illness or social situation that would preclude study compliance; Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel<br>Patients received pemetrexed 500mg/m2 days 1,29+cisplatin 25 mg/m2 days 1-3,29-31 + Radiation 6000 cGy (200 cGy/day). Patients with complete response(CR), partial response(PR) or stable disease(SD) with manageable toxicity received docetaxel 60 mg/m2 days 57,78. | Drug: pemetrexed<br>* Pemetrexed 500mg/m2 IV on day 1 every 4 weeks for 2 cycles<br>Drug: cisplatin<br>* Cisplatin 25mg/m2 IV on day 1-3 every 4 weeks for 2 cycles<br>* Other names: platinol;Radiation: thoracic radiation therapy<br>* Chemoradiotherapy, radiation 60Gy with 2 cycles of pemetrexed+ carboplatin/cisplatin<br>Drug: docetaxel<br>* Docetaxel 60 mg/m2 IV on day 57 every 3 weeks for 2 cycles<br>* Other names: taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 3 years | 
| Local control rate |  | 3 years | 
| The short-term quality of life (QOL) assessed using FACT-E score | FACT-E score at the 4 months after docetaxel consolidation therapy | 4 months | 
| Rate of CTCAE grade 2 or higher radiation pneumonitis | The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Squamous cell lung cancer, Pemetrexed, Radiosensitivity