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

NCT ID: NCT00682383

Last Updated: 2012-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2010-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ARM 1

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

Group Type: OTHER

Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta

Intervention Type: 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

Interventions

Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• Fine needle aspiration, core needle or Wang needle biopsy under CT or bronchoscopic fluoroscopic guidance of enlarged contralateral N3 mediastinal nodes
• Contralateral mediastinal nodes >2 cm on CT scan
• Contralateral node positivity on PET scan
• Right sided primary with paralyzed left true vocal cord
• Any of the following T4 lesions: Tumor of any size that invades any of the following: mediastinum, heart, great vessels, trachea, esophagus, vertebral body or carina:

• Written documentation of type of T4 extent by attending surgeon if the patient has had an exploratory thoracotomy or thoracoscopy
• T4 involvement of the trachea or carina by direct bronchoscopic visualization
• T4 involvement of the heart, esophagus, aorta, or vertebral body documented by CT scan, MRI or transesophageal ultrasound
• T4 involvement of the mediastinum may also be accepted by CT or MRI criteria if, in absence of the above organ involvement, there is a soft tissue extension directly into the mediastinal space.
• Radiographic criteria for involvement of main pulmonary artery or vein is allowed only if there is a mediastinal soft tissue mass.
• Age > 18 years
• ECOG performance status 0 or 1
• Ability to give informed consent
• Adequate organ and marrow function as evidenced by the following peripheral blood counts or serum chemistries at study entry:

• WBC > 4,000/µL
• Absolute neutrophil count > 1,500/mm3
• Platelet count > 100 x 103 cells/mm3
• Bilirubin < 1.5 x institutional ULN
• AST or ALT < 2.5 x institutional ULN
• Alkaline Phosphatase <2.5 x institutional ULN
• Serum Creatinine < 2.0mg/dL and/or adequate creatinine clearance
• Adequate pulmonary function (FEV>1.5 liters, or if <1.5 liters, the predicted FEV1of the contralateral lung must be >800 cc based on the quantitative split function testing. (Predicted FEV1= FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report)
• Must have one measurable lesion by chest X-ray or CT scan. Lesion(s) must be accurately measured in at least one dimension (longest diameter to be recorded) as >20mm with conventional techniques or as >10mm with spiral CT scan
• Men and women of childbearing potential must agree to use effective contraception while on treatment and for 6 months after treatment

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Mt. Sinai Medical Center, Miami

OTHER

Sponsor Role: lead

Responsible Party

Rogerio Lilenbaum, M.D.

Principal Investigator Rogerio Lilenbaum, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rogerio Lilenbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Medical Center

Miami Beach, Florida, United States

Countries

United States

Other Identifiers

LUN 07

Identifier Type: -

Identifier Source: org_study_id