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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Paclitaxel, Cisplatin, Pegfilgrastim
Sponsored by
Central European Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring NSCLC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • AKH, Universitätsklinik für Innere Medizin 1
  • Somogy Country Pulmo and Cardio Hospital,
  • Markusovszky Hospital
  • M. Sklodowska-Curie Memorial Dep. Of Lung and Thoracic Tumours,
  • Klinika Chirurgii Instytutu Gruzlicy i Chorob Pluc

Outcomes

Primary Outcome Measures

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

>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
- overall survival
> to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13)

Full Information

First Posted
February 14, 2006
Last Updated
April 30, 2012
Sponsor
Central European Cooperative Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00291850
Brief Title
Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
no patient recruitment
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central European Cooperative Oncology Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Paclitaxel, Cisplatin, Pegfilgrastim
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
>To evaluate the safety of neo-adjuvant chemotherapy with PC
Title
- to characterize the toxicity of PC, include febrile neutropenia.
Title
- to evaluate peri- and post-operative mortality
Title
> to determine the pathological complete response rate
Title
> to determine the complete tumor resection rate
Title
> 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.
Title
> To evaluate the following time-to-event efficacy variables:
Title
- disease free survival
Title
- overall survival
Title
> to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maciej Krzakowski, MD
Organizational Affiliation
M.Sklodowska-Curie Memorial, Dep of Lung and Thoracic Tumours, Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
AKH, Universitätsklinik für Innere Medizin 1
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Somogy Country Pulmo and Cardio Hospital,
City
Mosdos
Country
Hungary
Facility Name
Markusovszky Hospital
City
Szombathely
Country
Hungary
Facility Name
M. Sklodowska-Curie Memorial Dep. Of Lung and Thoracic Tumours,
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Klinika Chirurgii Instytutu Gruzlicy i Chorob Pluc
City
Warszawa
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

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