Combined Modality Therapy With Growth Factor Support in Locally Advanced Non-small Cell Lung Cancer (NSCLC)

NCT00682383 | Completed Phase 2 DMC

• 1 other identifier: LUN 07
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety and efficacy of administering filgrastim with concurrent chemoradiotherapy and the potential benefit of administering pegfilgrastim with consolidation chemotherapy in patients with unresectable locally advanced NSCLC patients.

Conditions

Unresectable Locally Advanced NSCLC

Keywords

Advanced NSCLC; Lung Cancer; Mount Sinai Medical Center CCOP

Outcome Measures

Primary Outcomes (1)

• To determine the safety and efficacy of administering pegfilgrastim with concurrent chemoradiotherapy and the potential benefit of administering pegfilgramstim with consolidation chemotherapy in patients with unresectable locally advanced NSCLC patients.

  One year

Secondary Outcomes (1)

• To determine the frequency of dose reductions, dose delays, and dose omissions during chemoradiotherapy with filgrastim and consolidation therapy with pegfilgrastim.

  One year

Study Arms (1)

ARM 1

OTHER

Cisplatin 75 mg/m2 day 1 and 22 Etoposide 80mg/m2 days 1-3, 22-24 Radiation therapy: (initial fields 1.8gy/day (5 weeks) to 45Gy, then boost 2.0Gy/day (8 days) to a total of 61Gy) beginning day 1 (Total elapsed time: approximately 6 weeks, 3 days) Filgrastim 5µg/kg\* SQ injection days 4-13 and days 25-34 Docetaxel 75mg/m2 Q 3 Weeks X 3 Cycles Pegfilgrastim 6 mg SQ injection day 2 of each cycle

Drug: Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta

Interventions

Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta DRUG

Cisplatin 75 mg/m2 day 1 and 22 Etoposide 80mg/m2 days 1-3, 22-24 Radiation therapy: (initial fields 1.8gy/day (5 weeks) to 45Gy, then boost 2.0Gy/day (8 days) to a total of 61Gy) beginning day 1 (Total elapsed time: approximately 6 weeks, 3 days) Filgrastim 5µg/kg\* SQ injection days 4-13 and days 25-34 Docetaxel 75mg/m2 Q 3 Weeks X 3 Cycles Pegfilgrastim 6 mg SQ injection day 2 of each cycle

ARM 1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed NSCLC: Either histologic or cytologic proof of a newly diagnosed non-small cell lung cancer is required. A biopsy with histology is preferred, but cytology is allowed. Histology or cytology from involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., a second biopsy will not be required).
• Patients with two or more parenchymal lesions on same or opposite sides of the lung are ineligible.
• Must have unresectable Stage IIIA (N2) or IIIB disease and also satisfy the following criteria:
• Unresectable Stage IIIA (N2) patients:
• N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or X-ray, such that, in the opinion of the treating investigator, the patient is not a candidate for induction chemotherapy or chemoradiotherapy followed by surgical resection.
• N2 status must be documented by any one of the following methods:
• Histologic or cytologic proof of N2 disease by exploratory thoracotomy, thoracoscopy, mediastinoscopy, mediastinotomy, Wang needle biopsy, fine needle aspiration under bronchoscopic or CT guidance or other method
• Node positivity by PET scan
• Nodes \>2 cm on CT scan
• Paralyzed left true vocal cord with separate left lung primary distinct from AP window nodes on CT Scan
• Stage IIIB patients:
• Pathologic documented or radiographically documented positive N3 nodes.
• Patients with positive supraclavicular or scalene lymph nodes must not have disease extending up into the cervical region evidenced by one of the following:
• Fine needle aspiration, core needle biopsy or excisional biopsy of supraclavicular N3 nodes
• Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy, mediastinotomy, or thoracotomy

You may not qualify if:

• Malignant pleural or pericardial effusion
• Prior chemotherapy or radiation therapy
• Pregnant or lactating females
• Primary malignancy other than basal or squamous carcinoma of the skin or carcinoma in situ of the cervix, or any other cancer for which the patient has been disease free for five years. Other in situ malignancies (e.g. breast, bladder, etc) in the past 3 years are permissible
• Unintentional weight loss \>10% body weight within the last 3 months
• Unable to provide informed consent
• Any pre-malignant myeloid condition or any malignancy with myeloid characteristics
• Active infection
• Known hypersensitivity to E. coli-derived proteins, pegfilgrastim, Filgrastim, or any other component of the product
• Significant nonmalignant disease including: documented HIV infection; uncontrolled heart disease, and poorly controlled diabetes
• Treatment within the last 30 days with any experimental agent

Sponsors & Collaborators

• Mt. Sinai Medical Center, Miami: lead
• Amgen: collaborator

Study Sites (1)

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cisplatin; Etoposide; Radiotherapy; Docetaxel; pegfilgrastim

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Rogerio Lilenbaum, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Rogerio Lilenbaum, M.D.

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 22, 2008
• Study Start: September 1, 2003
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

US (1)