Clinical trial NCT00905983: Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients
Official title: Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma, Non-Small-Cell
Elderly patients
Docetaxel
Gemcitabine
Lead sponsor: Hospital Arnau de Vilanova
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 48
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lung cancer is one of the most common malignancies worldwide and the leading cause of cancer-related deaths in Western countries. Standard treatment for patients with good performance status (PS) stage IIIB/IV NSCLC currently includes a two-drug platinum-based chemotherapy regimen, but optimum treatment for elderly patients is less well-defined due to platinum related toxicities. Several drugs with novel mechanisms of action and significant activity in NSCLC have been developed; including docetaxel and gemcitabine that are also active in patients previously treated with cisplatin-based regimens and have a more favorable toxicity profile. The more favorable toxicity profile of docetaxel and gemcitabine supports its use as first-line chemotherapy, especially in patients with severe comorbidities as elderly patients. To improve the therapeutic index of this combination, the investigators performed a study with biweekly gemcitabine and docetaxel in elderly patients.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced NSCLC.
* Stage III with pleural effusion and stage IV.
* Patients are 70 years old.
* Patients with 1 \> ECOG PS =1.
* 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; Leukocyte count \>= 4000x10(6)/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.
* 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 to study drugs.
* 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 & 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 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 Sánchez, 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 Gómez, 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 Althaia, Xarxa Asistencial de Manresa
name: Silvia Catot, Doctor
role: PRINCIPAL_INVESTIGATOR
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