Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Hospital Arnau de Vilanova.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospital Arnau de Vilanova
Information provided by:
Hospital Arnau de Vilanova
ClinicalTrials.gov Identifier:
NCT00906061
First received: May 19, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
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Purpose
There is little information of Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent.
This low rate makes the investigators think about the possibility of a bias selection, due to the existence of this exclusion criteria that do not permit to include patients with deteriorated performance status.
In these types of patients, the toxicity is an important issue to decide the therapeutic strategy. Gemcitabine and Docetaxel combination is very interesting because they have a different toxicity profile. This combination has demonstrated activity in several types of tumours, as breast cancer, sarcoma and lung cancer.
The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel; activity and dose intensity will be the same, but toxicity will be significantly low.
| 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 Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2 |
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 and 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 ]
| Estimated Enrollment: | 76 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 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: | 18 Years and older |
| 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 with ECOG PS 2.
- 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; 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.
- Prior radiotherapy for NSCLC.
- 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 study drugs.
- Pregnant or lactating women (women of childbearing potential must use adequate contraception).
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906061
Contacts
| Contact: Oscar Juan, Doctor | 0034963868501 | juan_osc@gva.es |
| Contact: Vicente Alberola, Doctor | 0034649974055 | alberola_vicara@gva.es |
Locations
| Spain | |
| Hospital Virgen de los Lirios | Recruiting |
| Alcoy, Alicante, Spain, 03804 | |
| Contact: Francisco Aparisi, Doctor 0034966528804 joseponcelorenzo@hotmail.com | |
| Principal Investigator: Francisco Aparisi, Doctor | |
| Hospital Clínica de Benidorm | Recruiting |
| Benidorm, Alicante, Spain, 03501 | |
| Contact: Gaspar Esquerdo, Doctor 0034965853850 gesquerdo@clinicabenidorm.com | |
| Principal Investigator: Gaspar Esquerdo, Doctor | |
| Hospital General de Elda | Recruiting |
| Elda, Alicante, Spain, 03600 | |
| Contact: Sonia Maciá, Doctor 0034966989109 smacia@tiscali.es | |
| Principal Investigator: Sonia Maciá, Doctor | |
| Hospital Althaia, Xarxa Asistencial de Manresa | Recruiting |
| Manresa, Barcelona, Spain, 08243 | |
| Contact: Siliva Catot, Doctor 0034938742112 ext 3319 scatot@althaia.cat | |
| Principal Investigator: Silvia Catot, Doctor | |
| Hospital Provincial de Castellón | Recruiting |
| Castellón de la Plana, Castellón, Spain, 12002 | |
| Contact: Alfreso Sánchez, Doctor 0034964354350 asanchezh@seom.org | |
| Principal Investigator: Alfredo Sánchez, Doctor | |
| Hospital de Sagunto | Recruiting |
| Sagunto, Valencia, Spain, 46520 | |
| Contact: Vicente Marco, Doctor 0034962659405 vginermaco@hotmail.com | |
| Principal Investigator: Vicente Giner, Doctor | |
| Hospital San Juan de Alicante | Recruiting |
| Alicante, Spain, 03550 | |
| Contact: Antonio López, Doctor 0034965938639 aljimenez73@hotmail.com | |
| Principal Investigator: Antonio López, Doctor | |
| Hospital Universitario de Alicante | Recruiting |
| Alicante, Spain, 03010 | |
| Contact: Juan L. Martí, Doctor 0034965938912 juanluismarti@hotmail.com | |
| Principal Investigator: Juan L. Martí, Doctor | |
| Instituto Valenciano de Oncología | Recruiting |
| Valencia, Spain, 46009 | |
| Contact: Miguel A. Muñoz, Doctor 0034961114013 eclinicos@fivo.org | |
| Principal Investigator: Miguel A. Muñoz, Doctor | |
| Hospital Arnau de Vilanova | Recruiting |
| Valencia, Spain, 46015 | |
| Contact: Oscar Juan, Doctor 0034963868500 juan_osc@gva.es | |
| Principal Investigator: Oscar Juan, Doctor | |
| Hospital Universitario La Fe | Recruiting |
| Valencia, Spain, 46009 | |
| Contact: José Gómez, Doctor 0034961973138 gcodina@ono.com | |
| Principal Investigator: José Gómez, Doctor | |
| Hospital Universitario Dr. Peset | Recruiting |
| Valencia, Spain, 46017 | |
| Contact: José muñoz, Doctor 0034961262300 munyoz_joslan@gva.es | |
| Principal Investigator: José Muñoz, Doctor | |
Sponsors and Collaborators
Hospital Arnau de Vilanova
Investigators
| Study Director: | Oscar Juan, Doctor | Hospital Arnau de Vilanova de Valencia |
| Principal Investigator: | Alfredo Sanchez, 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 Gomez, 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: | Juan L. Martí, Doctor | Hospital Universitario de Alicante |
| Principal Investigator: | Silvia Catot, Doctor | Hospital Althaia, Xarxa Asistencial de Manresa |
More Information
No publications provided
| Responsible Party: | Vicente Alberola Candel, ASOCIACIÓN TERAPEUTICA EN HEMATOLOGÍA Y ONCOLOGÍA MÉDICAS H. ARNAU DE VILANOVA |
| ClinicalTrials.gov Identifier: | NCT00906061 History of Changes |
| Other Study ID Numbers: | CPNM-PS2-07 |
| 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, Small Cell Lung Neoplasms Docetaxel Gemcitabine ECOG 2 |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Gemcitabine |
Docetaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 19, 2013