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

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

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.

Study Overview

• Status: Unknown
• Conditions: Squamous Cell Lung Cancer
• Intervention / Treatment: Drug: pemetrexed; Drug: cisplatin; Radiation: thoracic radiation therapy; Drug: docetaxel

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Hangzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel; 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; Pemetrexed 500mg/m2 IV on day 1 every 4 weeks for 2 cycles; Drug: cisplatin; Cisplatin 25mg/m2 IV on day 1-3 every 4 weeks for 2 cycles; Other Names: platinol; Radiation: thoracic radiation therapy; Chemoradiotherapy, radiation 60Gy with 2 cycles of pemetrexed+ carboplatin/cisplatin; Drug: docetaxel; Docetaxel 60 mg/m2 IV on day 57 every 3 weeks for 2 cycles; Other Names: taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Response Rate	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival		3 years
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
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

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ANTICIPATED): October 1, 2019
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: April 22, 2016
• First Submitted That Met QC Criteria: May 31, 2016
• First Posted (ESTIMATE): June 1, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): November 25, 2016
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Pemetrexed; Squamous cell lung cancer; Radiosensitivity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Folic Acid Antagonists; Docetaxel; Cisplatin; Pemetrexed
• Other Study ID Numbers: HZCH-2016-10