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

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Gemcitabine and Docetaxel	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Gemcitabine Docetaxel Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Hospital Arnau de Vilanova:

Primary Outcome Measures:

Overall response rate = sum of complete and partial tumour responses divided by the number of included patients [ Time Frame: 2 & 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: time from study entry to death from any cause ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: biweekly ] [ Designated as safety issue: Yes ]
Duration of response [ Time Frame: time from first response (CR or PR) to tumor progression ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: time from study entry to observed tumor progression or death due to progression disease ] [ Designated as safety issue: No ]
Measurement of quality of life [ Time Frame: 28 days ] [ Designated as safety issue: No ]


Enrollment:	48
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Gemcitabine and Docetaxel Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.	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

Eligibility


Ages Eligible for Study:	70 Years and older (Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905983

Locations


Spain
Hospital Virgen de los Lirios
Alcoy, Alicante, Spain, 3804
Hospital Clínica de Benidorm
Benidorm, Alicante, Spain, 03501
Hospital General de Elda
Elda, Alicante, Spain, 03600
Hospital Althaia, Xarxa Asistencial de Manresa
Manresa, Barcelona, Spain, 08243
Hospital Provincial de Castellón
Castellón de la Plana, Castellón, Spain, 12002
Hospital de Sagunto
Sagunto, Valencia, Spain, 46520
Hospital San Juan de Alicante
Alicante, Spain, 03550
Hospital Universitario La Fe
Valencia, Spain, 46009
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Hospital Arnau de Vilanova
Valencia, Spain, 46015
Hospital Universitario Dr. Peset
Valencia, Spain, 46017

Sponsors and Collaborators

Hospital Arnau de Vilanova

Investigators


Study Director:	Oscar Juan, Doctor	Hospital Arnau de Vilanova de Valencia
Principal Investigator:	Alfredo Sánchez, Doctor	Hospital Provincial de Castellón
Principal Investigator:	José Muñoz, Doctor	H. Universitario Dr. Peset
Principal Investigator:	Sonia Maciá, Doctor	Hospital General de Elda
Principal Investigator:	Vicente Giner, Doctor	Hospital de Sagunto
Principal Investigator:	José Gómez, Doctor	Hospital Universitario La Fe
Principal Investigator:	Gaspar Esquerdo, Doctor	Hospital Clínica de Benidorm
Principal Investigator:	Antonio López, Doctor	Hospital San Juan de Alicante
Principal Investigator:	Francisco Aparisi, Doctor	Hospital Virgen de los Lirios
Principal Investigator:	Miguel A. Muñoz, Doctor	Instituto Valenciano de Oncología
Principal Investigator:	Silvia Catot, Doctor	Hospital Althaia, Xarxa Asistencial de Manresa

More Information


Responsible Party:	Vicente Alberola Candel, ASOCIACIÓN TERAPEUTICA EN HEMATOLOGÍA Y ONCOLOGÍA MÉDICAS H. ARNAU DE VILANOVA
ClinicalTrials.gov Identifier:	NCT00905983 History of Changes
Other Study ID Numbers:	CPNM-ANC-07
Study First Received:	May 19, 2009
Last Updated:	May 19, 2009
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Arnau de Vilanova:


Carcinoma, Non-Small-Cell Elderly patients Docetaxel Gemcitabine

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Docetaxel Antimetabolites, Antineoplastic	Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators

ClinicalTrials.gov processed this record on September 26, 2016