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

Non-small Cell Lung Cancer Clinical Trial

Official title:

Dose-Dense Induction/Neoadjuvant Chemotherapy in the Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer With Additional Genomic Analyses to Identify Signatures Predictive of Chemotherapy Response.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02157116
• Other study ID #: Pro00004682
• Status: Terminated
• Phase: Phase 2
• First received: May 29, 2014
• Last updated: June 5, 2014
• Start date: May 2006
• Est. completion date: January 2010

Study information

• Verified date: June 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: January 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• cisplatin

• Docetaxel

• Pegfilgrastim

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction Response	Response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Response is defined as the number patients with a Complete Response (CR), disappearance of all target lesions, or a Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions.	Between 2 and 3 weeks after induction	No
Primary	Differential Gene Expression Between Responsive and Resistant Tumor Treated With Dose-dense Therapy		at the end of the study, estimated 2.5 years	No
Secondary	Number of Grade III/IV Hematologic Adverse Events		During induction chemotherapy, approximately 6 weeks	Yes
Secondary	Number of Grade III/IV Non-hematologic Adverse Events		During induction chemotherapy, approximately 6 weeks	Yes
Secondary	Number of Patients Who Were Able to Maintain Hemoglobin Between 11-13 g/dL During Induction		During induction, approximately 6 weeks	Yes
Secondary	Overall Survival		Approximately 10 years	No