Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Hospital Arnau de Vilanova.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Hospital Arnau de Vilanova
ClinicalTrials.gov Identifier:
NCT00905983
First Posted: May 21, 2009
Last Update Posted: May 21, 2009
Information provided by:
Hospital Arnau de Vilanova
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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: | Intervention Model: Single Group Assignment Masking: None (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:
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 ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: time from study entry to death from any cause ]
- Toxicity [ Time Frame: biweekly ]
- Duration of response [ Time Frame: time from first response (CR or PR) to tumor progression ]
- Time to progression [ Time Frame: time from study entry to observed tumor progression or death due to progression disease ]
- Measurement of quality of life [ Time Frame: 28 days ]
| 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
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| Ages Eligible for Study: | 70 Years and older (Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| First Submitted: | May 19, 2009 |
| First Posted: | May 21, 2009 |
| Last Update Posted: | May 21, 2009 |
| Last Verified: | May 2009 |
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 |