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Non-Small Cell Lung CancerPhase 2NCT00231465

Phase II Study of Docetaxel + ZD1839 in Elderly Patients With Non-Small Cell Lung Cancer

A Phase 2 study testing docetaxel (Taxotere®) and ZD1839 in people with Non-Small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

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

Official record
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Trial summary

This is a Phase II, open-label trial of Taxotere® + ZD1839 in elderly patients with Stage III-b or IV NSCLC who have received no prior chemotherapy for metastatic disease. Patients with prior adjuvant chemotherapy were allowed to enroll on this trial. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
docetaxel (Taxotere®) and ZD1839
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
Jul 2003to Aug 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients must be greater than or equal to 70 years of age.
  • Patients must have histologically confirmed non-small cell lung cancer (NSCLC) that is Stage IIIb (with pleural effusions) or Stage IV.
  • Patients must be previously untreated for metastatic disease but may have received previous adjuvant chemotherapy more than six months prior to registration. Patients may also have received radiation therapy for advanced disease; however there should be measurable disease outside the radiation ports.
  • Disease must be at least unidimensionally measurable. Lesions, which are located within a previously irradiated field, are not considered measurable unless there is a documented growth in its size.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Laboratory values must be as follows: White blood cell count greater than or equal to 3,000/mm^3; Absolute neutrophil count greater than or equal to 1,500/mm^3; Platelets greater than or equal to 100,000/mm^3; Total bilirubin less than or equal to 1.0 x institutional upper normal limit; Serum creatinine less than or equal to 2 x institutional upper normal limit; aspartic transaminase (AST) or ALANINE TRANSAMINASE (ALT) less than or equal to 1.5 x institutional upper normal limit; Alkaline Phosphatase less than or equal to 1.5 x institutional upper normal limit; Serum calcium less than or equal to 1.5 x institutional upper normal limit (corrected for serum albumin).
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  • Patients with combined alkaline phosphatase, AST and/or ALT elevations will not be allowed to enroll on protocol.
  • Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia.
  • In keeping with the policies of the institution, patients must sign an informed consent form indicating that they are aware of the investigational nature of this study
  • Patients with stable brain metastases after completion of radiation will be allowed to enroll in this trial.
  • Patients treated with adjuvant therapy more than six months ago will be allowed to enroll in this trial.
  • Cognitively impaired patients will be allowed to enroll on the trial if the legal guardian signs the consent form after a full informed consent process is completed. Whenever feasible the cognitively impaired person will also give assent to participation in the trial.

Who cannot join

  • Patients previously treated with chemotherapy or ZD1839.
  • Patients with known or clinical evidence of active central nervous system (CNS) metastasis. Patients with stable, previously treated brain metastases will be allowed.
  • Male Patients with female sexual partners in the reproductive age group who refuse to use effective methods of contraception will be excluded from the trial.
  • Patients with concurrent serious infections (i.e., receiving an intravenous antibiotic) are not eligible.
  • Patients with an unstable or serious concurrent medical condition are excluded. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, grade 3 neuropathies, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
  • Patients receiving other non-approved or investigational therapy concurrently or within 30 days of Day 1 of trial treatment.
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  • Patients with a history of other cancers except basal cell skin cancers, carcinoma of the cervix in situ, or curatively-treated cancers with > 2 years non-recurrence prior to entry in the trial. Patients with a history of other cancers must have histological confirmation that current disease is compatible with diagnosis of NSCLC.
  • Peripheral neuropathy >2. (Peripheral neuropathy must be < grade 1)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Docetaxel, ZD 1839, Polysorbate 80, or other agents used in the study.
  • Patients with combined alkaline phosphatase, AST and/or ALT elevations will be excluded from this protocol.
  • Patients previously treated with radiation therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase II Study of Taxotere® (Docetaxel) + ZD1839 (IRESSA®) in Previously Untreated Elderly Patients (≥70 Years Old) With Stage III-b (With Malignant Pleural Effusion [MPE+]) or Stage IV Non-Small Cell Lung Cancer (NSCLC)

This is a Phase II, open-label trial of Taxotere® + ZD1839 in elderly patients with Stage III-b or IV NSCLC who have received no prior chemotherapy for metastatic disease. Patients with prior adjuvant chemotherapy were allowed to enroll on this trial.

Read the detailed description

This trial is designed to test the efficacy and tolerability of a standard chemotherapy agent, Docetaxel, in combination with an oral agent, Iressa, in elderly patients with advanced stage lung cancer. Current practices utilize two chemotherapeutic medications that may result in increased toxicities and poor outcomes in the elderly population. Treatment consists of an infusion of docetaxel every 21 days for four doses while taking Iressa every day. A computed tomography (CT) scan will measure disease response after two cycles. Response determines continuation of treatment. Lab work will be collected before every treatment. Side effect information will also be collected at every visit. Once the infusion phase of the study is completed, a maintenance phase of taking just the Iressa begins and disease assessment occurs every two months. This period will last until disease progression is demonstrated.

Being tested
docetaxel (Taxotere®), ZD1839
Keywords
elderly, malignant pleural effusion
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Pleural Effusion, Malignant

What participants receive

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

  • docetaxel (Taxotere®)Drug

    Also called Taxotere®

    Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.

  • ZD1839Drug

    Also called IRESSA®, gefitinib

    ZD1839 will be continued until progression, or until trial closure, whichever comes first.

Study groups in NCT00231465
Study groupRoleWhat they receive
Taxotere® (Docetaxel) + ZD1839 (IRESSA®)ExperimentalPatients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle. ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
Receives: Drug: docetaxel (Taxotere®); Drug: ZD1839

What is being measured

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

  1. Overall Response Rate (ORR)

    ORR: Complete Response (CR) + Partial Response (PR). Response rate for Elderly (> 70 years) previously untreated patients with Stage IIIb (With Malignant Pleural Effusion (MPE)) or IV non-small cell lung cancer (NSCLC) receiving Taxotere + ZD1839. Best clinical response to treatment with combination was determined using Response Evaluation Criteria in Solid Tumors (RECIST V1.0): * Complete Response (CR)- Disappearance of all target lesions; * Partial Response (PR)- At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; * Progressive Disease (PD)- At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; * Stable Disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

    Measured: Duration of time on study, an average of 19 months

Secondary outcomes (2)

  1. Progression Free Survival (PFS) Rate

    PFS was calculated from the date of enrollment to the date of progression. All 44 treated were assessed for PFS, with a minimum follow-up of 19 months. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Duration of time on study, an average of 19 months

  2. Overall Survival (OS) Rate

    OS was calculated from the date of enrollment to the date of death. All 44 treated were assessed for OS, with a minimum follow-up of 19 months.

    Measured: Duration of time on study, an average of 19 months

Timeline

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

  1. First posted4 Oct 2005 (estimated)
  2. Study startJul 2003
  3. Primary completionAug 2012
  4. Study completionAug 2012

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00231465
Sponsor's protocol ID
MCC-12905
Other IDs
1839US/0205
Status last verified
Aug 2012
First submitted
3 Oct 2005
Last updated
3 Mar 2017
Data monitoring committee
Yes

Publications

  • Simon GR, Extermann M, Chiappori A, Williams CC, Begum M, Kapoor R, Haura EB, Ismail-Khan R, Schell MJ, Antonia SJ, Bepler G. Phase 2 trial of docetaxel and gefitinib in the first-line treatment of patients with advanced nonsmall-cell lung cancer (NSCLC) who are 70 years of age or older. Cancer. 2008 May 1;112(9):2021-9. doi: 10.1002/cncr.23360.

    PubMed 18300255

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel (Taxotere®) and ZD1839 in people with Non-Small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

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 12 inclusion and 11 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 3 Mar 2017. 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 United States. 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?

Yes. Results are posted in the registry (first posted 30 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Response Rate (ORR) (time frame: Duration of time on study, an average of 19 months). 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 NCT00231465, which also lists 1 linked publication.

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 3 Mar 2017.

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