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

NCT02157116 | Terminated Phase 2 Results

• 1 other identifier: Pro00004682
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Dose-Dense Chemotherapy

Outcome Measures

Primary Outcomes (2)

• 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

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

  at the end of the study, estimated 2.5 years

Secondary Outcomes (4)

• Number of Grade III/IV Hematologic Adverse Events

  During induction chemotherapy, approximately 6 weeks

• Number of Grade III/IV Non-hematologic Adverse Events

  During induction chemotherapy, approximately 6 weeks

• Number of Patients Who Were Able to Maintain Hemoglobin Between 11-13 g/dL During Induction

  During induction, approximately 6 weeks

• Overall Survival

  Approximately 10 years

Study Arms (1)

Induction Chemotherapy

EXPERIMENTAL

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

Drug: cisplatin; Drug: Docetaxel; Drug: Pegfilgrastim

Interventions

cisplatin DRUG

Also known as: Platinol

Induction Chemotherapy

Docetaxel DRUG

Also known as: Taxotere

Induction Chemotherapy

Pegfilgrastim DRUG

Also known as: Neulasta

Induction Chemotherapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Sanofi: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Docetaxel; pegfilgrastim

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; 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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Richard Riedel, MD
• Organization: Duke University

richard.riedel@duke.edu

919-681-6932

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 5, 2014
• Study Start: May 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2010
• Last Updated: July 4, 2014
• Results First Posted: July 4, 2014

Record last verified: 2014-06

Locations

US (1)