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Study of Erlotinib With Docetaxel in Selected Non Small Cell Lung Cancer Patients in First Line Treatment

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ClinicalTrials.gov Identifier: NCT00840125
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : October 30, 2012
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Tracking Information
First Submitted Date  ICMJE February 9, 2009
First Posted Date  ICMJE February 10, 2009
Last Update Posted Date October 30, 2012
Study Start Date  ICMJE February 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
all cause mortality [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00840125 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Erlotinib With Docetaxel in Selected Non Small Cell Lung Cancer Patients in First Line Treatment
Official Title  ICMJE A Phase II Open-Label Study Designed to Evaluate the Efficacy and Safety, of Erlotinib in Combination With Docetaxel in Selected Non Small Cell Lung Cancer Patients Eligible for First Line Treatment
Brief Summary

Study Rationale:

There is increasing evidence that erlotinib improves overall survival in selected patients with stage IIIB-IV NSCLC. Furthermore, pre-clinical and phase II studies have shown a potential for synergism between erlotinib and docetaxel. This study will further evaluate the effects of combination treatment on overall survival in selected NSCLC patient population.

Based on recent published data, the treatment cycle in this study will be 22 days with two infusions (Day 1 and Day 8 of each cycle). This is different from the standard therapy care of 28-day cycle (three infusions on Days 1, 8 and 15). The shorter 22-day cycle was shown to be just as effective as the 28-day cycle and is expected to increase subject compliance and decrease chemotherapy-induced toxicity.

Study Objectives:

The primary objective is to demonstrate superiority in progression-free-survival, when erlotinib is added to docetaxel.

The secondary objectives are to determine:

  • Overall survival (defined as the time period from the start of first-line therapy to death)
  • Time to treatment failure or disease progression (defined as the time period from the start of first-line therapy to investigator assessed disease progression)
  • Tumor response rate and duration
  • Safety profile
  • Quality of Life improvement
  • microRNA profile (assessed from human lung biopsy and/or cytology samples) at screening for prognostic purposes
Detailed Description

Study Design:

This will be a Phase II, open-label, single-center, repeat dose, study. After a two-week screening phase, eligible subjects will receive combined docetaxel and erlotinib treatment over six cycles. Each 22-day treatment cycle will consist of two infusion of docetaxel, one-week apart followed by one week rest, and daily administration of erlotinib. Subjects, who complete six cycles of combination therapy, will continue receiving erlotinib monotherapy for as long as they are benefiting from this therapy in the opinion of the investigator (i.e. until continued toxicity or disease progression or withdrawal from the study). Subjects will be evaluated for safety and radiologic tumor assessment throughout the study until death. The study will be terminated after every living patient has had a follow up of at least 6 months after stopping TarcevaTM, or when all patients have died.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: erlotinib
    150mg tablet daily
    Other Name: tarceva
  • Drug: docetaxel
    30 mg/m2 days 1,8 of 22 days cycles, up to 6 cycles
    Other Name: taxotere
Study Arms  ICMJE Experimental: 1
docetaxel + erlotinib
Interventions:
  • Drug: erlotinib
  • Drug: docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2012)
4
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2009)
40
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female subjects, above 18 years of age at the time of enrollment.
  2. Subject aged 18-65 must have ECOG performance status of 2 and subjects above 65 must have ECOG PS 0-2.
  3. Histological or cytological documented diagnosis of inoperable, locally advanced (with pleural effusion), recurrent or metastatic (Stage IIIB or Stage IV) NSCLC.
  4. Patients must have evidence of measurable disease with at least one measurable or evaluable lesion.
  5. Eligible for first line monotherapy treatment (or no prior chemotherapy or radiation treatments for this indication). Palliative localized radiation is allowed.
  6. Life expectancy of at least 12 weeks.
  7. Adequate bone marrow function as shown by: WBC >= 3.0 x 109/L, ANC >=1.5 x 109/L, Platelets >=100 x 109/L, Hgb >=10g/dL.
  8. Subjects must have normal organ function as defined below:

    • AST (SGOT) / ALT (SGPT) ≤ 2 x upper limit of normal (ULN),
    • Serum creatinine ≤ 1.5 x ULN or creatinine clearance > 60 ml/min
    • Coagulation markers - PT and PTT (or INR) within normal limits unless subjects are already anti-coagulated for other reasons (i.e., atrial fibrillation, etc.).
  9. Signed written informed consent to participate in the study.
  10. Ability to comply with the requirements of the study.

Exclusion Criteria:

  1. Participation in an investigational trial within 30 days of the screening visit.
  2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib or docetaxel.
  3. Have a previous (unless disease free for more than five years) or concurrent malignancy besides NSCLC (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
  4. Subjects with known brain metastases or spinal cord compression that is newly diagnosed and/or has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression with evidence of stable disease (clinically stable imaging) for at least 2 months is permitted..
  5. Subjects with preexisting neuropathy ≥ grade 2.
  6. Current serious infections.
  7. Current known acute or chronic infection with HBV or HCV.
  8. Known human immunodeficiency virus (HIV) infection.
  9. Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient's treating Oncologist and the ophthalmologist.
  10. Subjects with other concurrent severe and/or uncontrolled medical condition which could compromise participation in the study (i.e. active infection, uncontrolled diabetes, uncontrolled hypertension - grade 4, congestive cardiac failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal or metabolic disease, active upper GI tract ulceration).
  11. Any chronic or acute condition susceptible of interfering with the evaluation of drug effect.
  12. Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder or any chronic condition susceptible, in the opinion of the investigator, of interfering with the conduct of the study.
  13. Organ allograft or previous history of stem cell transplantation.
  14. Subjects who received anti-neoplastic therapy, radiation therapy or had surgery within 28 days prior to the start of study agent administration or who have not recovered from the toxic effects of such therapy. Palliative localized radiation is allowed.
  15. Subjects who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
  16. Fertile subjects who are not willing to use an acceptable method of contraception during the treatment period and for 28 days following completion of treatment.
  17. For women of child-bearing potential: A positive pregnancy test at screening or breast-feeding.
  18. Subjects who are likely to be non-compliant or uncooperative during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00840125
Other Study ID Numbers  ICMJE MG-NSCLC-2008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meir Medical Center
Study Sponsor  ICMJE Meir Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maya Gottfried, MD Meir Medical Center
PRS Account Meir Medical Center
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP