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

Phase 2
18 Years
65 Years
Not Enrolling
Non-Small Cell Lung Cancer

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Trial Information

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

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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

the evaluation of the clinical response rate of neo-adjuvant chemotherapy with dose-dense therapy of paclitaxel and cisplatin(PC) with peg-filgrastim in patients with operable NSCLC

Principal Investigator

Maciej Krzakowski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.Sklodowska-Curie Memorial, Dep of Lung and Thoracic Tumours, Warsaw


Austria: Federal Ministry for Health and Women

Study ID:




Start Date:

June 2005

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms