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

Primary Purpose

Non-small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
Docetaxel
Pegfilgrastim
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Dose-Dense Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Induction Chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Differential Gene Expression Between Responsive and Resistant Tumor Treated With Dose-dense Therapy

Secondary Outcome Measures

Number of Grade III/IV Hematologic Adverse Events
Number of Grade III/IV Non-hematologic Adverse Events
Number of Patients Who Were Able to Maintain Hemoglobin Between 11-13 g/dL During Induction
Overall Survival

Full Information

First Posted
May 29, 2014
Last Updated
June 5, 2014
Sponsor
Duke University
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02157116
Brief Title
Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient accrual to meet analysis goals
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Dose-Dense Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induction Chemotherapy
Arm Type
Experimental
Arm Description
Cisplatin 75mg/m2 IV days 1, 15, 29; Docetaxel 75mg/m2 IV days 1, 15, 29; and Pegfilgrastim 6mg SC day 2, 16, 30
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
Platinol
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Neulasta
Primary Outcome Measure Information:
Title
Induction Response
Description
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.
Time Frame
Between 2 and 3 weeks after induction
Title
Differential Gene Expression Between Responsive and Resistant Tumor Treated With Dose-dense Therapy
Time Frame
at the end of the study, estimated 2.5 years
Secondary Outcome Measure Information:
Title
Number of Grade III/IV Hematologic Adverse Events
Time Frame
During induction chemotherapy, approximately 6 weeks
Title
Number of Grade III/IV Non-hematologic Adverse Events
Time Frame
During induction chemotherapy, approximately 6 weeks
Title
Number of Patients Who Were Able to Maintain Hemoglobin Between 11-13 g/dL During Induction
Time Frame
During induction, approximately 6 weeks
Title
Overall Survival
Time Frame
Approximately 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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

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