Clinical trial NCT00291850: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
Lead sponsor: Central European Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2006-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
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 outcomes:
measure: >To evaluate the safety of neo-adjuvant chemotherapy with PC
measure: - to characterize the toxicity of PC, include febrile neutropenia.
measure: - to evaluate peri- and post-operative mortality
measure: > to determine the pathological complete response rate
measure: > to determine the complete tumor resection rate
measure: > 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.
measure: > To evaluate the following time-to-event efficacy variables:
measure: - disease free survival
measure: - overall survival
measure: > to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AKH, Universitätsklinik für Innere Medizin 1
city: Mosdos
country: Hungary
facility: Somogy Country Pulmo and Cardio Hospital,
city: Szombathely
country: Hungary
facility: Markusovszky Hospital
city: Warszawa
country: Poland
facility: M. Sklodowska-Curie Memorial Dep. Of Lung and Thoracic Tumours,
city: Warszawa
country: Poland
facility: Klinika Chirurgii Instytutu Gruzlicy i Chorob Pluc
Study officials:
affiliation: M.Sklodowska-Curie Memorial, Dep of Lung and Thoracic Tumours, Warsaw
name: Maciej Krzakowski, MD
role: PRINCIPAL_INVESTIGATOR
References: