Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients

NCT ID: NCT00905983

Last Updated: 2009-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-09-30

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine and Docetaxel

Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.

Group Type: EXPERIMENTAL

Gemcitabine and Docetaxel

Intervention Type: DRUG

Docetaxel 50 mg/m2, IV, and Gemcitabine 2000 mg/m2, IV, on day 1 and 14 of each 28 day cycle. Number of Cycles: 6

Interventions

Gemcitabine and Docetaxel

Docetaxel 50 mg/m2, IV, and Gemcitabine 2000 mg/m2, IV, on day 1 and 14 of each 28 day cycle. Number of Cycles: 6

Intervention Type: DRUG

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Arnau de Vilanova

OTHER

Sponsor Role: lead

Responsible Party

ASOCIACIÓN TERAPEUTICA EN HEMATOLOGÍA Y ONCOLOGÍA MÉDICAS H. ARNAU DE VILANOVA

Principal Investigators

Oscar Juan, Doctor

Role: STUDY_DIRECTOR

Hospital Arnau de Vilanova de Valencia

Alfredo Sánchez, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital Provincial de Castellón

José Muñoz, Doctor

Role: PRINCIPAL_INVESTIGATOR

H. Universitario Dr. Peset

Sonia Maciá, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital General de Elda

Vicente Giner, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital de Sagunto

José Gómez, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Fe

Gaspar Esquerdo, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínica de Benidorm

Antonio López, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital San Juan de Alicante

Francisco Aparisi, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de los Lirios

Miguel A. Muñoz, Doctor

Role: PRINCIPAL_INVESTIGATOR

Instituto Valenciano de Oncología

Silvia Catot, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital Althaia, Xarxa Asistencial de Manresa

Locations

Hospital Virgen de los Lirios

Alcoy, Alicante, Spain

Hospital San Juan de Alicante

Alicante, Alicante, Spain

Hospital Clínica de Benidorm

Benidorm, Alicante, Spain

Hospital General de Elda

Elda, Alicante, Spain

Hospital Althaia, Xarxa Asistencial de Manresa

Manresa, Barcelona, Spain

Hospital Provincial de Castellón

Castellon, Castellón, Spain

Hospital de Sagunto

Sagunto, Valencia, Spain

Hospital Universitario La Fe

Valencia, Valencia, Spain

Instituto Valenciano de Oncología

Valencia, Valencia, Spain

Hospital Arnau de Vilanova

Valencia, Valencia, Spain

Hospital Universitario Dr. Peset

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

CPNM-ANC-07

Identifier Type: -

Identifier Source: org_study_id