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.

Study Overview

• Status: Terminated
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Paclitaxel, Cisplatin, Pegfilgrastim

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • AKH, Universitätsklinik für Innere Medizin 1
• Hungary
  • Mosdos, Hungary
    • Somogy Country Pulmo and Cardio Hospital,
  • Szombathely, Hungary
    • Markusovszky Hospital
• Poland
  • Warszawa, Poland, 02-781
    • M. Sklodowska-Curie Memorial Dep. Of Lung and Thoracic Tumours,
  • Warszawa, Poland
    • Klinika Chirurgii Instytutu Gruzlicy i Chorob Pluc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
- overall survival
>To evaluate the safety of neo-adjuvant chemotherapy with PC
- to characterize the toxicity of PC, include febrile neutropenia.
- to evaluate peri- and post-operative mortality
> to determine the pathological complete response rate
> to determine the complete tumor resection rate
> to evaluate proportion of cycle 2 and all cycles chemotherapy given with planned dose-on-time and proportion of patients receiving planned dose-on-time in cycle 2 and over all cycles.
> To evaluate the following time-to-event efficacy variables:
- disease free survival
> to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13)

Collaborators and Investigators

• Sponsor: Central European Cooperative Oncology Group
• Investigators: Principal Investigator: Maciej Krzakowski, MD, M.Sklodowska-Curie Memorial, Dep of Lung and Thoracic Tumours, Warsaw

Study record dates

Study Major Dates

• Study Start: June 1, 2005

Study Registration Dates

• First Submitted: February 14, 2006
• First Submitted That Met QC Criteria: February 14, 2006
• First Posted (Estimate): February 15, 2006

Study Record Updates

• Last Update Posted (Estimate): May 1, 2012
• Last Update Submitted That Met QC Criteria: April 30, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Cisplatin
• Other Study ID Numbers: CECOG/NSCLC.3.2.002