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

Duke University

Status and phase

Terminated

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: cisplatin

Drug: Docetaxel

Drug: Pegfilgrastim

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02157116

Pro00004682

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.