Docetaxel Intermittent-Erlotinib (Tarceva®) In Metastatic Non Small Cell Lung Cancer (NSCLC) (DOPERLO)

This study has been terminated.
(The low accrual rate of the study (30% of the expected accrual rate)/Low efficacy in both treatment arms.)
Sponsor:
Information provided by:
Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00783471
First received: October 30, 2008
Last updated: June 15, 2010
Last verified: June 2010
  Purpose

To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced Non-Small-Lung-Cancer


Condition Intervention Phase
Advanced Non-Small Cell Lung Cancer
Drug: Erlotinib, Docetaxel
Drug: Docetaxel, Erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Docetaxel Combined With Pulsatile Erlotinib (Tarceva®) In Patients With Metastatic Non Small Cell Lung Cancer (NSCLC) (DOPERLO)

Resource links provided by NLM:


Further study details as provided by Hellenic Cooperative Oncology Group:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: Assessment every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: November 2008
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Erlotinib followed by Docetaxel
Drug: Erlotinib, 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, 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients aged 18 to 75 years inclusive, with histologically confirmed metastatic NSCLC will be enrolled.
  2. Patients must have not been previously treated with anticancer drugs for advanced disease.
  3. ECOG performance status of 0 - 1.
  4. Life expectancy of at least 12 weeks.
  5. Patients must be able to take oral medication.
  6. 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
  7. Granulocyte count > 1,500/mm3 and platelet count > 100,000/mm3. Haemoglobin ³ 9.0g/dl.
  8. 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
  9. 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
  10. Serum creatinine <= 1.5 ULN or creatinine clearance > 60 ml/min.
  11. Normal serum calcium.
  12. For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting Tarceva/placebo treatment.
  13. Patients with reproductive potential must use effective contraception.
  14. Able to comply with study and follow-up procedures.
  15. Written (signed) Informed Consent to participate in the study.
  16. Written (signed) Informed Consent for use of tumour samples.
  17. Presence of measurable or evaluable disease (lesions that are present but do not fulfil the criteria for measurable disease).
  18. 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:

  1. Prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab, trastuzumab).
  2. 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.
  3. Patients who have undergone complete tumour resection after responding to platinum based chemotherapy.
  4. 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.
  5. Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
  6. 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.
  7. Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids are excluded.
  8. Any inflammatory changes of the surface of the eye.
  9. Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
  10. Nursing and/or pregnant women.
  11. Hypersensitivity to erlotinib (Tarceva) or to docetaxel or to any of the excipients.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783471

Locations
Greece
Hygeia Hospital
Athens, Greece, 15123
Sotiria Hospital
Athens, Greece, 11526
"Attikon" University Hospital, 2nd Dept. of Internal Medicine, Propaedeutic, Oncology Section
Athens, Greece, 12461
Agii Anargiri Cancer Hospital, 3rd Dept. of Medical Oncology
Athens, Greece, 14564
"Alexandra" Hospital
Athens, Greece, 11528
University General Hospital of Ioannina, Medical Oncology Dept
Ioannina, Greece, 45500
Larissa University Hospital
Larissa, Greece, 41110
Metropolitan Hospital, Second Dept of Medical Oncology
Piraeus, Greece, 18547
Metropolitan Hospital, 1st Dept. of Medical Oncology
Pireaus, Greece, 18547
Patras University Hospital, Dept. of Internal Medicine, Oncology Section
Rio, Patras, Greece, 26500
"Papageorgiou" Hospital
Thessaloniki, Greece, 56403
Theagenio Cancer Hospital, 3rd Dept. of Medical Oncology
Thessaloniki, Greece, 54007
Theagenio Cancer Hospital, 2nd Dept of Medical Oncology
Thessaloniki, Greece, 54007
Sponsors and Collaborators
Hellenic Cooperative Oncology Group
Investigators
Principal Investigator: Evangelos Briasoulis, MD University of Ioannina Hospital, Medical School
  More Information

No publications provided

Responsible Party: G. Fountzilas/President, Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00783471     History of Changes
Other Study ID Numbers: HE 2D/07
Study First Received: October 30, 2008
Last Updated: June 15, 2010
Health Authority: Greece: Ethics Committee
Greece: National Organization of Medicines

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
Docetaxel
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014