AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 2NCT00840125

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

A Phase 2 study testing erlotinib and docetaxel in people with Non-Small Cell Lung Cancer, run by Meir Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
erlotinib and docetaxel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteIsrael
Study dates
Feb 2009to Aug 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects, above 18 years of age at the time of enrollment.
  • Subject aged 18-65 must have ECOG performance status of 2 and subjects above 65 must have ECOG PS 0-2.
  • Histological or cytological documented diagnosis of inoperable, locally advanced (with pleural effusion), recurrent or metastatic (Stage IIIB or Stage IV) NSCLC.
  • Patients must have evidence of measurable disease with at least one measurable or evaluable lesion.
  • Eligible for first line monotherapy treatment (or no prior chemotherapy or radiation treatments for this indication). Palliative localized radiation is allowed.
  • Life expectancy of at least 12 weeks.
Show all 13Show fewer
  • 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.
  • 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.).
  • Signed written informed consent to participate in the study.
  • Ability to comply with the requirements of the study.

Who cannot join

  • Participation in an investigational trial within 30 days of the screening visit.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib or docetaxel.
  • 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).
  • 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..
  • Subjects with preexisting neuropathy ≥ grade 2.
  • Current serious infections.
Show all 18Show fewer
  • Current known acute or chronic infection with HBV or HCV.
  • Known human immunodeficiency virus (HIV) infection.
  • 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.
  • 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).
  • Any chronic or acute condition susceptible of interfering with the evaluation of drug effect.
  • 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.
  • Organ allograft or previous history of stem cell transplantation.
  • 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.
  • Subjects who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
  • 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.
  • For women of child-bearing potential: A positive pregnancy test at screening or breast-feeding.
  • Subjects who are likely to be non-compliant or uncooperative during the study.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Meir Medical Center

    Kfar Saba, Israel, 44281

Other trials in Israel

About this study

Official title: 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

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.

Read more

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
Read the 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.

Being tested
erlotinib, docetaxel
Keywords
NSCLC, ERLOTINIB, DOCETAXEL, first line treatment, Stage IIIB /IV, not previously treated, ECOG PS 2 or age over 65
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erlotinibDrug

    Also called tarceva

    150mg tablet daily

  • docetaxelDrug

    Also called taxotere

    30 mg/m2 days 1,8 of 22 days cycles, up to 6 cycles

Study groups in NCT00840125
Study groupRoleWhat they receive
1Experimentaldocetaxel + erlotinib
Receives: Drug: erlotinib; Drug: docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. all cause mortality

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionDec 2010
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00840125
Sponsor's protocol ID
MG-NSCLC-2008
Status last verified
Oct 2012
First submitted
9 Feb 2009
Last updated
30 Oct 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib and docetaxel in people with Non-Small Cell Lung Cancer, run by Meir Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

all cause mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00840125.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in