Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer

NCT ID: NCT02157116

Last Updated: 2014-07-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2010-01-31

Brief Summary

Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less time between treatments than in standard chemotherapy. The two chemotherapy drugs used in this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given every 21 days. This study is exploring the response to chemotherapy when these drugs are given every 14 days. In addition, genetic tests will be performed on pre-treatment specimens to identify signatures that may predict chemotherapy sensitivity or resistance.

Detailed Description

All patients will receive induction chemotherapy with cisplatin and docetaxel. Pegfilgrastim will be administered approximately 24 hours following the end of the day 1 chemotherapy infusion. Cycles will be repeated every 2 weeks for 3 cycles. Patients deemed to be resectable will undergo surgical resection followed by postoperative thoracic radiotherapy. Patients deemed inoperable will additionally receive concurrent chemoradiotherapy. Response, using radiographic and/or pathologic means, will identify two cohorts; responders and nonresponders.Gene expression profiling will then be performed on pre-treatment specimens to identify signatures that predict for chemotherapy sensitivity or resistance.

The target enrollment is 45 patients.

Conditions

Non-small Cell Lung Cancer

Study Design

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

Study Groups

Induction Chemotherapy

Cisplatin 75mg/m2 IV days 1, 15, 29; Docetaxel 75mg/m2 IV days 1, 15, 29; and Pegfilgrastim 6mg SC day 2, 16, 30

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

Docetaxel

Intervention Type: DRUG

Pegfilgrastim

Intervention Type: DRUG

Interventions

cisplatin

Intervention Type: DRUG

Docetaxel

Intervention Type: DRUG

Pegfilgrastim

Intervention Type: DRUG

Other Intervention Names

Platinol; Taxotere; Neulasta

Eligibility Criteria

Inclusion Criteria

• Patients with documented stage III NSCLC (IIIA or IIIB, without malignant pleural/pericardial effusion) are eligible for enrollment if they are considered appropriate for treatment with chemotherapy, radiation, or surgery;
• IIIA: T1-3 N2 M0, T3 N1 M0
• IIIB: T4 N0-2 M0, T 1-4 N3 M0
• Measurable or evaluable disease
• Previously untreated with chemotherapy or radiotherapy for lung cancer;
• No brain metastases;
• No prior XRT
• Performance status 0-2
• ≥18 years of age
• Informed Consent
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelets ≥ 100 x 109/L
• Bilirubin ≤ 1.5 x upper limit of normal for the institution (ULN)
• SGOT and SGPT ≤ 2.5 x ULN for the institution
• Creatinine ≤ 1.6 mg/dL
• Hemoglobin ≥ 8.0 g/dL
• Peripheral neuropathy ≤ grade 1

Exclusion Criteria

• Known sensitivity to E. coli derived products (e.g. Filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® Growth Hormone, INTRON® A);
• Use of IV systemic antibiotics within 72 hours prior to chemotherapy;
• Known HIV infection
• Lithium or cytokines within 2 weeks prior of entry
• Additional concurrent investigational drugs
• History of myelodysplastic syndrome
• Pregnant, nursing or having unprotected sex
• Not available for follow-up assessment
• Unable to comply with protocol procedures
• Illnesses that may compromise ability to give informed consent.
• Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.

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

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00004682

Identifier Type: -

Identifier Source: org_study_id