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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00291850
• Other study ID #: CECOG/NSCLC.3.2.002
• Status: Terminated
• Phase: Phase 2
• First received: February 14, 2006
• Last updated: April 30, 2012
• Start date: June 2005

Study information

• Verified date: April 2012
• Source: Central European Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Paclitaxel, Cisplatin, Pegfilgrastim

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Central European Cooperative Oncology Group

Countries where clinical trial is conducted

Austria,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	>To evaluate the safety of neo-adjuvant chemotherapy with PC
Secondary	- to characterize the toxicity of PC, include febrile neutropenia.
Secondary	- to evaluate peri- and post-operative mortality
Secondary	> to determine the pathological complete response rate
Secondary	> to determine the complete tumor resection rate
Secondary	> 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.
Secondary	> To evaluate the following time-to-event efficacy variables:
Secondary	- disease free survival
Secondary	- overall survival
Secondary	> to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13)