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Docetaxel Combined With Pulsatile Erlotinib (Tarceva®) In Patients With Metastatic Non Small Cell Lung Cancer (NSCLC) (DOPERLO)

Phase 2
18 Years
75 Years
Not Enrolling
Advanced Non-Small Cell Lung Cancer

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Trial Information

Docetaxel Combined With Pulsatile Erlotinib (Tarceva®) In Patients With Metastatic Non Small Cell Lung Cancer (NSCLC) (DOPERLO)

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.

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

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

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,

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

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

10. Nursing and/or pregnant women.

11. Hypersensitivity to erlotinib (Tarceva) or to docetaxel or to any of the excipients.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Time Frame:

Assessment every 6 weeks

Safety Issue:


Principal Investigator

Evangelos Briasoulis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Ioannina Hospital, Medical School


Greece: Ethics Committee

Study ID:

HE 2D/07



Start Date:

November 2008

Completion Date:

June 2010

Related Keywords:

  • Advanced Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms