- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00783471
Docetaxel Intermittent-Erlotinib (Tarceva®) In Metastatic Non Small Cell Lung Cancer (NSCLC) (DOPERLO)
June 15, 2010 updated by: Hellenic Cooperative Oncology Group
Docetaxel Combined With Pulsatile Erlotinib (Tarceva®) In Patients With Metastatic Non Small Cell Lung Cancer (NSCLC) (DOPERLO)
To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced Non-Small-Lung-Cancer
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The combination of chemotherapy [such as docetaxel] with continuous administration of targeted drugs which block the molecular machinery of cancer cell growth [such as erlotinib] have failed to improve their efficacy over only-chemotherapy in patients with metastatic lung cancer of the non-small cell histology type.
It is not yet known whether administering targeted drugs intermittently could result in improved efficacy of the combinations.
This is a multicenter randomized Phase II trial aiming to determine the more active dosing sequence between intermittent erlotinib and docetaxel for treating patients with advanced Non-Small-Lung-Cancer.Patients will be randomly assigned to one of two treatment arms: they will receive a 12-days course of erlotinib either before docetaxel [arm A] or after docetaxel administration [arm B].Treatment will be repeated every 21 days.Patients will be evaluated every 2 cycles (~6 weeks) for response using RECIST criteria.
Those patients achieving stable disease or better will continue therapy up to a total 8 cycles.
Those patients experiencing progressive disease will be taken off study.
Biopsy material will be assessed for biomarkers.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Athens, Greece, 11526
- Sotiria Hospital
-
Athens, Greece, 11528
- "Alexandra" Hospital
-
Athens, Greece, 12461
- "Attikon" University Hospital, 2nd Dept. of Internal Medicine, Propaedeutic, Oncology Section
-
Athens, Greece, 14564
- Agii Anargiri Cancer Hospital, 3rd Dept. of Medical Oncology
-
Athens, Greece, 15123
- Hygeia Hospital
-
Ioannina, Greece, 45500
- University General Hospital of Ioannina, Medical Oncology Dept
-
Larissa, Greece, 41110
- Larissa University Hospital
-
Piraeus, Greece, 18547
- Metropolitan Hospital, Second Dept of Medical Oncology
-
Pireaus, Greece, 18547
- Metropolitan Hospital, 1st Dept. of Medical Oncology
-
Rio, Patras, Greece, 26500
- Patras University Hospital, Dept. of Internal Medicine, Oncology Section
-
Thessaloniki, Greece, 54007
- Theagenio Cancer Hospital, 2nd Dept of Medical Oncology
-
Thessaloniki, Greece, 54007
- Theagenio Cancer Hospital, 3rd Dept. of Medical Oncology
-
Thessaloniki, Greece, 56403
- "Papageorgiou" Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female patients aged 18 to 75 years inclusive, with histologically confirmed metastatic NSCLC will be enrolled.
- Patients must have not been previously treated with anticancer drugs for advanced disease.
- ECOG performance status of 0 - 1.
- Life expectancy of at least 12 weeks.
- Patients must be able to take oral medication.
- At least 4 weeks since any prior major surgery or extended-field radiotherapy. Patients who, in the opinion of the investigator, have fully recovered from limited surgery or have undergone limited-field radiotherapy within 2 weeks may also be considered eligible for the study
- Granulocyte count > 1,500/mm3 and platelet count > 100,000/mm3. Haemoglobin ³ 9.0g/dl.
- SGOT (AST) and SGPT (ALT) < 2,5 x ULN in the absence of liver metastases or up to 5 x ULN in case of liver metastases
- Alkaline phosphatase (ALP) < 2,5 x ULN. If alkaline phosphatase is > 2.5 x ULN, SGOT (AST) and SGPT (ALT) must be < 1.5 x ULN. If alkaline phosphatase is ³ 2.5 x ULN in the presence of liver metastases, SGOT and SGPT must be < 5 x ULN
- Serum creatinine <= 1.5 ULN or creatinine clearance > 60 ml/min.
- Normal serum calcium.
- For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting Tarceva/placebo treatment.
- Patients with reproductive potential must use effective contraception.
- Able to comply with study and follow-up procedures.
- Written (signed) Informed Consent to participate in the study.
- Written (signed) Informed Consent for use of tumour samples.
- Presence of measurable or evaluable disease (lesions that are present but do not fulfil the criteria for measurable disease).
- Formalin-fixed, paraffin-embedded tumour tissue samples representative of the tumour will be provided to sponsor within 3 weeks of the patient starting chemotherapy
Exclusion Criteria:
- Prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab, trastuzumab).
- Prior chemotherapy or therapy with systemic anti-neoplastic therapy (e.g., monoclonal antibody therapy) for advanced disease. Prior surgery and/or localised irradiation is permitted.
- Patients who have undergone complete tumour resection after responding to platinum based chemotherapy.
- Any unstable systemic disease (including active infections, significant cardiovascular disease, [including myocardial infarction within the previous year], any significant hepatic, renal or metabolic disease) metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medication(s) or that might affect the interpretation of the results or render the patient at high risk from treatment complications.
- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- Patients are excluded if they have symptomatic brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; patients with CNS metastases with evidence of stable disease (clinically stable imaging) and stable neurologic function are allowed to enter the study.
- Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids are excluded.
- Any inflammatory changes of the surface of the eye.
- Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
- Nursing and/or pregnant women.
- Hypersensitivity to erlotinib (Tarceva) or to docetaxel or to any of the excipients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Erlotinib followed by Docetaxel
|
Drug: Erlotinib 150 mg po daily, days 1-12 Drug: Docetaxel 75 mg/m2 IV over 30 min on day 15 Treatment will be repeated every 21 days
|
Experimental: 2
Docetaxel followed by Erlotinib
|
Drug: Docetaxel 75 mg/m2 IV over 30 min on day 1 Drug: Erlotinib 150 mg po daily, days 4-15 Treatment will be repeated every 21 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival (PFS)
Time Frame: Assessment every 6 weeks
|
Assessment every 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare the Overall Survival (OS),the Objective Response Rate (ORR) and duration of response
Time Frame: Assessment every 6 weeks while on treatment and every 3 months post completion of 8 cycles of treatment until progression
|
Assessment every 6 weeks while on treatment and every 3 months post completion of 8 cycles of treatment until progression
|
Identify predictive signaling molecules of the EGFR pathway
Time Frame: Assessment every 6 weeks while on treatment and every 3 months post completion of 8 cycles of treatment until progression
|
Assessment every 6 weeks while on treatment and every 3 months post completion of 8 cycles of treatment until progression
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Evangelos Briasoulis, MD, University of Ioannina Hospital, Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
October 30, 2008
First Submitted That Met QC Criteria
October 30, 2008
First Posted (Estimate)
October 31, 2008
Study Record Updates
Last Update Posted (Estimate)
June 16, 2010
Last Update Submitted That Met QC Criteria
June 15, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protein Kinase Inhibitors
- Docetaxel
- Erlotinib Hydrochloride
Other Study ID Numbers
- HE 2D/07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Non-Small Cell Lung Cancer
-
Mythic TherapeuticsRecruitingNon-Small Cell Lung Cancer | NSCLC | Advanced Non-Small Cell Lung Cancer | NSCLC Stage IV | NSCLC Stage IIIB | Advanced Non-Small Cell Squamous Lung Cancer | Advanced Non-Small Cell Non-Squamous Lung CancerUnited States, Australia, Korea, Republic of, United Kingdom
-
AstraZenecaCompletedAdvanced Non Small Cell Lung Cancer | Advanced (Inoperable) Non Small Cell Lung CancerFrance, Korea, Republic of, United Kingdom, Spain
-
AstraZenecaCompletedAdvanced Non Small Cell Lung Cancer | Advanced (Inoperable) Non Small Cell Lung CancerBelgium, United States, Korea, Republic of, Taiwan, United Kingdom, Netherlands
-
AstraZenecaCompletedAdvanced Non Small Cell Lung Cancer | Advanced (Inoperable) Non Small Cell Lung CancerUnited States, France, Germany, Korea, Republic of, Taiwan, United Kingdom, Spain, Italy, Japan, Australia
-
Peking University First HospitalMerck Sharp & Dohme LLCNot yet recruitingAdvanced Non-squamous Non-small-cell Lung Cancer | Metastatic Non-squamous Non Small Cell Lung Cancer | Recurrent Non-Squamous Non-Small Cell Lung CancerChina
-
Gradalis, Inc.WithdrawnLung Neoplasms | Advanced Non-small Cell Lung Cancer | Metastatic Non-small Cell Lung CancerUnited States
-
LianBio LLCRecruitingAdvanced Solid Tumor | Advanced or Metastatic Non-small Cell Lung CancerChina
-
Gilead SciencesArcus Biosciences, Inc.RecruitingLung Cancer | Advanced or Metastatic Non-Small-Cell Lung Cancer | Resectable Non-Small-Cell Lung CancerUnited States, Korea, Republic of, Taiwan, Hong Kong, Israel, United Kingdom
-
Cancer Research UKBicycle TherapeuticsCompletedNon-Small Cell Lung Cancer | Advanced Solid Tumours | Oesophageal Cancer | Non-Small Cell Lung SarcomaUnited Kingdom
-
Mirati Therapeutics Inc.RecruitingAdvanced Non-Small Cell Lung Cancer | Metastatic Non-Small Cell Lung CancerUnited States, Korea, Republic of, Italy, Spain, Czechia, Hungary, Netherlands, Canada, Australia, Austria, Belgium, Germany, Ireland, Israel, Poland, United Kingdom, Taiwan, Portugal
Clinical Trials on Erlotinib, Docetaxel
-
Hospital Arnau de VilanovaUnknown
-
University Hospital, LimogesHoffmann-La RocheCompletedNon Small Cell Lung CancerFrance
-
Hoffmann-La RocheCompletedNon-Squamous Non-Small Cell Lung CancerItaly
-
National Taiwan University HospitalUnknownNon-small Cell Lung Cancer(NSCLC)Taiwan
-
Meir Medical CenterCompletedNon-Small Cell Lung CancerIsrael
-
Mirati Therapeutics Inc.TerminatedAdvanced Malignancies, Non-small Cell Lung CancerUnited States
-
Jonsson Comprehensive Cancer CenterAventis Pharmaceuticals; GenentecCompletedProstate CancerUnited States
-
Paula Silverman, MDNational Cancer Institute (NCI)CompletedBreast CancerUnited States
-
University of California, DavisNational Cancer Institute (NCI); Genentech, Inc.; Aventis PharmaceuticalsCompletedLung Cancer | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Fred Hutchinson Cancer CenterCompletedOvarian Cancer | Fallopian Tube Cancer | Peritoneal Cavity CancerUnited States