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

Central European Cooperative Oncology Group

Status and phase

Terminated

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Paclitaxel, Cisplatin, Pegfilgrastim

Study type

Interventional

Funder types

Other

Identifiers

NCT00291850

CECOG/NSCLC.3.2.002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.