Elderly Dependent Patients With Non Small Cell Lung Cancer (NSCLC)
This study has been completed.
Sponsor:
Groupe Francais De Pneumo-Cancerologie
Information provided by:
Groupe Francais De Pneumo-Cancerologie
ClinicalTrials.gov Identifier:
NCT00419042
First received: January 4, 2007
Last updated: March 8, 2010
Last verified: March 2010
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Purpose
The purpose of this study is in non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients with evaluation of the sequence Gemcitabine first line followed by Erlotinib when progression versus Erlotinib first line followed by Gemcitabine when progression
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Drug: TARCEVA Drug: Gemzar |
Phase 2 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Multicenter Randomized Phase II Trial in NSCLC Stage IV et IIIB in Elderly Dependent Patients With Evaluation of the Sequence Gemcitabine First Line Followed by Erlotinib When Progression Versus Erlotinib First Line Followed by Gemcitabine When Progression. |
Resource links provided by NLM:
Drug Information available for:
Gemcitabine
Gemcitabine hydrochloride
Erlotinib hydrochloride
Erlotinib
U.S. FDA Resources
Further study details as provided by Groupe Francais De Pneumo-Cancerologie:
| Enrollment: | 100 |
| Study Start Date: | July 2006 |
| Study Completion Date: | March 2010 |
Intervention Details:
Detailed Description:
-
Drug: TARCEVA
Tarceva (150 mg) is a pill you take once a day -- every day -- to help treat non-small cell lung cancer.
Other Name: Erlotinib
Drug: Gemzar
GEMZAR by mixing it into a solution and giving it through a needle into a vein—called intravenous infusion (IV). This will take about 30 minutes
Other Name: Gemcitabine
A multicenter phase II trial,prospective,randomized,open,non comparative
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients
Criteria
Inclusion Criteria:
- Age > 65
- Comorbidities score, PS and frailty score according to table 1
- No dementia, faecal or urinary incontinence, repeated falls
- ADL = 0, IADL = 0-1
- Life expectancy at least 12 weeks
- Creatinin clearance > = 30 ml/mn (according to Cockcrofts-Gault formula)
- Competency to give written informed consent
- Haematological functions as follows : neutrophiles count > 1.5 x 109/l and platelets > 100 x 109/l hemoglobin > 9,5 g/dl - Hepatic function as follows : Bilirubin < 1,25 LNS ASAT / ALAT <5 x NAlcPh <5 x N
- PS < 3
- cerebral metastasis eligible if asymptomatic
- Histologically or cytologically confirmed NSCLC
- Stage IV/IIIB4 (T4 with pleural effusion)
- No prior chemotherapy
- relapses of previous NSCLC treated by surgery or radiotherapy are eligible, if the target is measurable out of initial radiotherapy field and if cytological or histological proof
- At least one measurable target lesion by RECIST guidelines
Exclusion Criteria:
- symptomatic cerebral metastasis
- Any severe comorbidity calculated by Charlson score according to table 1
- ADL > 0 and IADL > 1- performance status >2 (ECOG)
- peripheral neuropathy grade 2 or more
- dementia, repeated falls, urinary or faecal incontinence
- contra-indication to corticosteroids
- contra indication to a product of this study
- unwilling or unable to comply with study requirements, for personal, family, sociologic, geographic or any other reason
- inability of the subject to give written informed consent
- lack of liberty following legal or administrative decision
- hypersensitivity to polysorbate
- hypersensitivity to erlotinib or any excipients of this product
- unusual hereditary disorders, as galactosemia, deficit in lactase and syndrome of malabsorption in glucose or galactose
- participation in concomitant clinical trial
- bronchioloalveolar or neuroendocrine or composite carcinoma
- superior vena cava syndrome
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419042
Locations
| France | |
| Site 12 | |
| Aix En Provence, France, 13100 | |
| Site 05 | |
| Bastia, France, 20200 | |
| Site 22 | |
| Beauvais, France, 60021 | |
| Site 43 | |
| Caen, France, 14000 | |
| Site 30 | |
| Charleville Mezieres, France, 08000 | |
| Site 33 | |
| Creteil, France, 94010 | |
| Site 07 | |
| Draguignan, France, 83300 | |
| Site 32 | |
| Elbeuf, France, 76503 | |
| Site 04 | |
| GAP, France, 05000 | |
| Site 41 | |
| Le Chesnay, France, 78157 | |
| Site 00 | |
| Limoges, France | |
| Site 25 | |
| Mantes La Jolie, France, 78200 | |
| Site 06 | |
| Marseille, France, 13274 | |
| Site 27 | |
| Martigues, France, 13695 | |
| Site 01 | |
| Meaux, France, 77108 | |
| Site 42 | |
| Orleans, France, 45032 | |
| Site 26 | |
| Paris, France, 75012 | |
| Site 19 | |
| Perigueux, France, 24019 | |
| Site 02 | |
| Reims, France, 51092 | |
| Site 20 | |
| Rennes, France, 35033 | |
| Site 17 | |
| Rouen, France, 76233 | |
| Site 14 | |
| Toulon, France, 83800 | |
| Site 11 | |
| Villefranche Sur Saone, France, 69655 | |
Sponsors and Collaborators
Groupe Francais De Pneumo-Cancerologie
Investigators
| Principal Investigator: | Hervé LECAER, Doctor | Groupe Francais De Pneumo-Cancerologie |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr LE CAER Hervé, GFPC |
| ClinicalTrials.gov Identifier: | NCT00419042 History of Changes |
| Other Study ID Numbers: | GFPC 05-05 |
| Study First Received: | January 4, 2007 |
| Last Updated: | March 8, 2010 |
| Health Authority: | France: Institutional Ethical Committee |
Keywords provided by Groupe Francais De Pneumo-Cancerologie:
|
cancer Lung cancer None small-cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Erlotinib 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 Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013