Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC

Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA Non-Small Cell Lung Cancer

A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy in this patient population.

This is an open-label, single-arm Phase II study of dose-dense regimen with paclitaxel and cisplatin supported by pegfilgrastim as neo-adjuvant chemotherapy in patients with operable stage II, IIA NSCLC.

Paclitaxel will be administered via intravenous infusion over approximately 3 hours at dose of 175mg/m2 on Day 1 of each 14-day cycle. Cisplatin 75mg/m2 will be given via intravenous infusion on day 1 (after paclitaxel) according to institutional guidelines.

Pegfilgrastim (Neulasta) fixed dose of 6mg (0.6mL of a 10mg/mL solution) as a single subcutaneous injection on Day 2 of each study cycle.

All drugs will be given in 2-weekly cycle. Three cycles of pre-operative chemotherapy are planned.

Inclusion Criteria:

• histologic or cytologic diagnosis of NSCLC
• Presence of clinical Stage IIA,IIB or IIA disease
• tumor amenable to curative surgical resection
• Patients with clinically measurable lesions will be enrolled in this study.
• No prior tumor therapy
• Performance status of 0-1 on ECOG Scale
• Patients compliance and geographic proximity that allow adequate follow-up.
• Medical fitness of patient, including respiratory function, adequate for radical NSCLC surgery.

Exclusion Criteria:

• Presence of clinical Stage IIIA disease, according to the revision by Mountain CF of American Joint Committee on Cancer.
• Treatment within the last 30 days with any investigational drug.
• Cocurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
• Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
• pregnancy/breast feeding
• Serious concomitant disorders that would compromise the safety of the patient or compromise the patients ability to complete the study, at the discretion of the investigator.
• poorly controlled diabetes mellitus
• Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
• History of significant neurological or mental disorder, including seizures or dementia.