Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT00291850
- Lead Sponsor
- Central European Cooperative Oncology Group
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method - disease free 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: - overall survival > to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13)
Trial Locations
- Locations (5)
AKH, Universitätsklinik für Innere Medizin 1
🇦🇹Vienna, Austria
Klinika Chirurgii Instytutu Gruzlicy i Chorob Pluc
🇵🇱Warszawa, Poland
Somogy Country Pulmo and Cardio Hospital,
🇭🇺Mosdos, Hungary
Markusovszky Hospital
🇭🇺Szombathely, Hungary
M. Sklodowska-Curie Memorial Dep. Of Lung and Thoracic Tumours,
🇵🇱Warszawa, Poland