Consolidation Chemotherapy/Concurrent Chemo-radiotherapy for Inoperable Stage III Non-small Cell Lung Cancer (NSCLC)

NCT01336543 | Withdrawn Phase 2 DMC

• 1 other identifier: H11-071
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot phase II study of histology based consolidation chemotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer (NSCLC) following concurrent chemo-radiotherapy. Patients with inoperable stage III NSCLC would be treated with standard concurrent chemo-radiotherapy and subsequently those with non-squamous histology would be offered 4 cycles of consolidation pemetrexed and those with squamous histology 4 cycles of consolidation with gemcitabine.

Conditions

Stage III Non-small Cell Lung Cancer

Keywords

Non small cell lung cancer; Inoperable Stage III; Inoperable; Stage III

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  From date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration.

  3 years

Study Arms (1)

Active Treatment

EXPERIMENTAL

ACTIVE TREATMENT intervention below: 1. NSCLC (Non-Small Cell Lung Cancer) 2. PE (Cisplatin 50mg/m2 on days 1,8,29,36 Etoposide 60 mg/m2 days 1-3 and 29-31) 3. Radiation 59.4 Gy with 2 cycles of PE 4. (Non-squamous histology) Pemetrexed consolidation 500mg/m2 every 21 days for 4 cycles 5. (Squamous histology) Gemcitabine consolidation 1000mg/m2 days 1,8, every 21 days for 4 cycles

Drug: Chemotherapy following concurrent Chemoradiotherapy

Interventions

Chemotherapy following concurrent Chemoradiotherapy DRUG

1. NSCLC (Non-Small Cell Lung Cancer) 2. PE (Cisplatin 50mg/m2 on days 1,8,29,36 Etoposide 80mg/m2 days 1-3 and 29-31) 3. Radiation 59.4 Gy with 2 cycles of PE 4. (Non-squamous histology) Pemetrexed consolidation 500mg/m2 every 21 days for 4 cycles 5. (Squamous histology) Gemcitabine consolidation 1000mg/m2 days 1,8, every 21 days for 4 cycles

Also known as: Pemetrexed, Gemcitabine, Cisplatin, Etoposide

Active Treatment

Eligibility Criteria

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

You may qualify if:

• Adult patients 18 years and older with histology proven NSCLC with inoperable stage III A or IIIB disease.
• Inoperable stage III A defined by multiple and or/bulky N2 mediastinal lymph nodes on computed tomography (CT) scan such that in opinion of treating investigator, the patient was not a candidate for surgical resection.
• N2 disease must be documented by either biopsy, fluorodeoxyglucose positron emission tomography (PET), and or CT scan if nodes are more than 2 cm.
• Stage IIIB patients must have N3 or T4 status. N3 status must be documented by presence of contralateral (to the primary tumor) mediastinal lymph node or supraclavicular or scalene lymph node proven by either biopsy, fluorodeoxyglucose PET, or more than 2 cm on CT scan.
• No prior treatment for lung cancer
• ECOG Performance status of 0-1.
• Initiation of consolidation chemotherapy within 4-8 weeks of concurrent chemo-radiotherapy without progression.
• Adequate organ function
• leukocytes \>3,000/mcL
• absolute neutrophil count \>1,500/mcL
• platelets \>100,000/mcL
• total bilirubin within normal institutional limits
• AST (SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
• creatinine within normal institutional limits OR
• creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

You may not qualify if:

• Patient who have had prior treatment for lung cancer.
• Prior history of radiation to chest.
• Known malignancy other than the current cancer.
• Uncontrolled intercurrent illness including but not limited to ongoing active infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within last six months or ventricular arrhythmias requiring medication, psychiatric illness that would impair patients ability to comply with study requirements.
• Pregnant or lactating women (any women becoming pregnant during the study will be withdrawn from the study)
• Patient with documented or symptoms of peripheral neuropathy.
• History of allergic reaction to compounds similar to the ones used in this study.
• Malignant effusions (pleural or pericardial)
• Superior sulcus (Pancoast) tumors.
• Any condition that would hamper ability to give informed consent or ability to comply with study protocol.
• HIV patients on anti-retroviral therapy are in-eligible to participate in this study because of potential interaction with the study drugs and increase susceptibility for infections during course of marrow suppressive chemotherapy and radiotherapy.

Sponsors & Collaborators

• Syed Jafri: lead

Study Sites (1)

LSU Health Sciences Center, 1501 Kings Highway

Shreveport, Louisiana, 71103, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Gemcitabine; Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Syed H. Jafri, MD

  LSU Health Shreveport, Feist-Weiller Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 18, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

US (1)