Clinical trial NCT00906061: Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
Official title: Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma, Small Cell
Lung Neoplasms
Docetaxel
Gemcitabine
ECOG 2
Lead sponsor: Hospital Arnau de Vilanova
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is little information of Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent.

This low rate makes the investigators think about the possibility of a bias selection, due to the existence of this exclusion criteria that do not permit to include patients with deteriorated performance status.

In these types of patients, the toxicity is an important issue to decide the therapeutic strategy. Gemcitabine and Docetaxel combination is very interesting because they have a different toxicity profile. This combination has demonstrated activity in several types of tumours, as breast cancer, sarcoma and lung cancer.

The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel; activity and dose intensity will be the same, but toxicity will be significantly low.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced NSCLC.
* Stage III with pleural effusion and stage IV.
* Patients with ECOG PS 2.
* Patients must have at least one measurable lesion, no previously irradiated.
* Life expectancy of at least 12 weeks.
* Adequate organ function according to the following criteria:

  * Bone marrow: ANC =\> 2.0x10(9)cells/L; Platelet count =\> 100x10(9)cells/L; Hemoglobin =\> 10 g/dL.
  * Liver function: Bilirubin \<= 1.5 X ULN; Alkaline phosphatase \<= 5 x ULN; AST and ALT \<= 1.5 x ULN.
  * Renal function:serum creatinine \<= 2mg/dL.

Exclusion Criteria:

* Prior systemic chemotherapy for advanced disease.
* Prior radiotherapy for NSCLC.
* Patients with symptomatic brain metastases.
* No measurable bone metastases or malignant pleural effusion as only measurable lesion.
* History of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
* History of hypersensitivity reaction study drugs.
* Pregnant or lactating women (women of childbearing potential must use adequate contraception).
* Concurrent treatment with other experimental drugs.
* Current peripheral neuropathy NCI grade 2.
* Participation in clinical trials within 30 days of study entry.
* Major surgery, open biopsy or traumatic lesion 28 days before to study start.

Primary outcomes:
measure: Overall response rate = sum of complete and partial tumour responses divided by the number of included patients
timeFrame: 2 and 4 months
Secondary outcomes:
measure: Overall survival
timeFrame: Time from study entry to death from any cause
measure: Toxicity
timeFrame: Biweekly
measure: Duration of response
timeFrame: time from first response (CR or PR) to tumor progression
measure: Time to progression
timeFrame: time from study entry to observed tumor progression or death due to progression disease
measure: Measurement of quality of life
timeFrame: 28 days
Other outcomes:
Locations:
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios
state: Alicante
city: Benidorm
country: Spain
facility: Hospital Clínica de Benidorm
state: Alicante
city: Elda
country: Spain
facility: Hospital General de Elda
state: Alicante
city: Manresa
country: Spain
facility: Hospital Althaia, Xarxa Asistencial de Manresa
state: Barcelona
city: Castellón de la Plana
country: Spain
facility: Hospital Provincial de Castellón
state: Castellón
city: Sagunto
country: Spain
facility: Hospital de Sagunto
state: Valencia
city: Alicante
country: Spain
facility: Hospital Universitario de Alicante
city: Alicante
country: Spain
facility: Hospital San Juan de Alicante
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
Study officials:
affiliation: Hospital Arnau de Vilanova de Valencia
name: Oscar Juan, Doctor
role: STUDY_DIRECTOR
affiliation: Hospital Provincial de Castellón
name: Alfredo Sanchez, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Universitario Dr. Peset
name: José Muñoz, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General de Elda
name: Sonia Maciá, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Sagunto
name: Vicente Giner, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Fe
name: José Gomez, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínica de Benidorm
name: Gaspar Esquerdo, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Juan de Alicante
name: Antonio López, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de los Lirios
name: Francisco Aparisi, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Valenciano de Oncología
name: Miguel A. Muñoz, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Alicante
name: Juan L. Martí, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Althaia, Xarxa Asistencial de Manresa
name: Silvia Catot, Doctor
role: PRINCIPAL_INVESTIGATOR
References: