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

Zhejiang University

Status and phase: Unknown; Phase 2

Conditions: Squamous Cell Lung Cancer

Treatments: Drug: docetaxel; Radiation: thoracic radiation therapy; Drug: cisplatin; Drug: pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT02787473

HZCH-2016-10

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel

Experimental group

Description:

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.

Treatment:

Radiation: thoracic radiation therapy

Drug: pemetrexed

Drug: cisplatin

Drug: docetaxel