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

NCT00905983 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2009-05-21

No results posted yet for this study

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

Interventions

DRUG

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

Sponsors & Collaborators

  • Hospital Arnau de Vilanova

    lead OTHER

Principal Investigators

  • Oscar Juan, Doctor · Hospital Arnau de Vilanova de Valencia

  • Alfredo Sánchez, Doctor · Hospital Provincial de Castellón

  • José Muñoz, Doctor · H. Universitario Dr. Peset

  • Sonia Maciá, Doctor · Hospital General de Elda

  • Vicente Giner, Doctor · Hospital de Sagunto

  • José Gómez, Doctor · Hospital Universitario La Fe

  • Gaspar Esquerdo, Doctor · Hospital Clínica de Benidorm

  • Antonio López, Doctor · Hospital San Juan de Alicante

  • Francisco Aparisi, Doctor · Hospital Virgen de los Lirios

  • Miguel A. Muñoz, Doctor · Instituto Valenciano de Oncología

  • Silvia Catot, Doctor · Hospital Althaia, Xarxa Asistencial de Manresa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-09-30
Completion
2011-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00905983 on ClinicalTrials.gov