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

NCT02787473 | Unknown Phase 2 DMC

• 1 other identifier: HZCH-2016-10
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Squamous Cell Lung Cancer

Keywords

Squamous cell lung cancer; Pemetrexed; Radiosensitivity

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  3 years

Secondary Outcomes (4)

• Overall Survival

  3 years

• Local control rate

  3 years

• The short-term quality of life (QOL) assessed using FACT-E score

  4 months

• Rate of CTCAE grade 2 or higher radiation pneumonitis

  1 years

Study Arms (1)

pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel

EXPERIMENTAL

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

Interventions

pemetrexed DRUG

Pemetrexed 500mg/m2 IV on day 1 every 4 weeks for 2 cycles

pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel

cisplatin DRUG

Cisplatin 25mg/m2 IV on day 1-3 every 4 weeks for 2 cycles

Also known as: platinol

pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel

thoracic radiation therapy RADIATION

Chemoradiotherapy, radiation 60Gy with 2 cycles of pemetrexed+ carboplatin/cisplatin

pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel

docetaxel DRUG

Docetaxel 60 mg/m2 IV on day 57 every 3 weeks for 2 cycles

Also known as: taxotere

pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Interventions

Pemetrexed; Cisplatin; Docetaxel

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Shenglin Ma, MD

CONTACT

0571-56007908; mashenglin@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: June 1, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: September 1, 2020
• Last Updated: November 25, 2016

Record last verified: 2016-11

Locations

CN (1)