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Breast NeoplasmsPhase 2NCT00052169

Therapy With Docetaxel and ZD1839 for Patients Who Have Advanced Breast Cancer

A Phase 2 study testing ZD1839 in combination with docetaxel in people with Breast Neoplasms, run by NSABP Foundation Inc 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

The purpose of this study is to learn how breast cancer tumors respond to treatment combining the drugs docetaxel and ZD1839. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
ZD1839 in combination with docetaxel
How many people
33 participants
Where
1 siteUnited States
Study dates
Jan 2003to Sep 2006
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic confirmation of breast cancer
  • Signed consent
  • Current diagnosis of metastatic breast cancer
  • At least one uni-dimensionally measurable lesion with clearly defined margins
  • Patients taking bisphosphonates for documented prior bone metastasis may be included
  • Patients may have received prior adjuvant chemotherapy including an anthracycline and/or an alkylating agent. Patients may have received prior paclitaxel or trastuzumab for adjuvant therapy. Patients may not have received prior docetaxel treatment
Show all 31Show fewer
  • Patients may have received unlimited prior hormonal therapy regimens for metastatic disease or adjuvant therapy and must have documentation of progressive disease prior to entry. Hormonal therapy must be discontinued at least 2 weeks prior to study entry
  • Patients may have received prior radiation therapy provided it was completed at least 2 weeks before study entry. Prior radiotherapy to treat bone metastasis or spinal cord compression is permitted provided it was completed prior to study entry
  • Zubrod performance status 0, 1, or 2
  • Life expectancy of 12 weeks or more in opinion of investigator
  • LVEF greater than or equal to LLN without clinical signs or symptoms of heart failure
  • adequate bone marrow, hepatic, and renal function
  • Ineligibility Criteria
  • Prior ZD1839 or other anti EGFR or small molecule TKI
  • Previous or concurrent chemo or Herceptin for metastatic breast cancer
  • Unresolved non-permanent major end organ chronic toxicity from previous anticancer therapy greater than CTC grade 2
  • Radiation therapy less than 14 days before study entry, with exception of RT to treat bone metastasis or spinal cord compression
  • Incomplete healing of surgical incision from previous major surgery
  • Newly diagnosed (within 12 weeks) intracerebral metastases
  • Signs of neurological symptoms consistent with new onset spinal cord compression
  • Evidence of severe or uncontrolled systemic disease
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for patient to participate
  • Pregnancy or breast feeding
  • Patients who are currently using contact lenses. Patients who discontinue wearing contact lenses prior to study entry are eligible.
  • Patients with untreated ocular inflammation or infection
  • Patients with contraindications to corticosteroid use
  • History of another malignancy within past 5 years that could confound diagnosis or staging of breast cancer
  • Patients receiving other investigational drugs
  • Previous docetaxel treatment
  • Patients currently taking systemic retinoids or herbal medicines
  • Patients currently taking drugs known to induce Cyt P4503A4

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NSABP Operations Center

    Pittsburgh, Pennsylvania, 15212

Other trials in United States

About this study

Official title: A Phase 2, Multi-Center Trial of ZD1839 (IRESSA) in Combination With Docetaxel as First-Line Treatment in Patients With Advanced Breast Cancer

The purpose of this study is to learn how breast cancer tumors respond to treatment combining the drugs docetaxel and ZD1839.

Read the detailed description

Patients with advanced breast cancer continue to have an extremely poor prognosis with an average life expectancy of approximately 2 years. Novel treatments designed to exploit biologic properties of the tumor are urgently required as a means to improve the outcome for the large numbers of patients who relapse after receiving optimal chemotherapy treatments.

Overexpresssion of EGFR and/or TGF-alpha is frequent in human breast cancer and has been correlated in many cases with poor prognostic features. Inhibition of the EGFR pathway has been proposed as a potential therapeutic modality in advanced breast cancer. The antiproliferative activity of ZD 1839 in combination with cytotoxic drugs, such as docetaxel was evaluated in breast cancer cell lines ZR-75-1 and MCF-10A ras that coexpress EGFR and TGF-alpha. Combination treatment demonstrated dose dependent supra-additive growth inhibition and markedly enhanced apoptotic cell death.

Although taxanes bind to the microtubular network in cells that is essential for mitotic and interphase cellular functions, the mechanism by which these agents induce cell death is not entirely clear. Docetaxel has also shown dose-dependent anti-angiogenic activity. Thus, the mechanism(s) of anti-tumor activity of docetaxel remain unclear and combinations of signal transduction pathway inhibition and/or anti-angiogenesis may provide potentiation of concurrent ZD 1839 and docetaxel therapy.

This phase 2 trial is designed to prospectively investigate the efficacy and safetey of combination therapy with ZD 1839 and docetaxel in patients with metastatic breast cancer.

Being tested
ZD1839 in combination with docetaxel
Keywords
metastatic breast cancer, docetaxel, Taxotere, ZD 1839, gefitinib, NSABP, advanced breast cancer, AstraZeneca
Medical subject headings
Breast Neoplasms

What participants receive

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

  • ZD1839 in combination with docetaxelDrug

    Also called Docetaxel (Taxotere), ZD1839, gefitinib (Iressa)

    Docetaxel given as 75 mg/m2 IV every 3 weeks combined with ZD1839 (IRESSA) 250 mg orally daily until disease progression or withdrawal criteria are met.

What is being measured

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

  1. To estimate the clinical benefit rate of the combination of ZD 1839 and docetaxel; clinical benefit measured by clinical response, pathologic response, and stable disease (SD greater than or equal to 24 weeks)

    Measured: 2 years

  2. To characterize the safety profile of the combination of ZD 1839 and docetaxel as measured by the frequency and severity of adverse events.

    Measured: 2 years

Secondary outcomes (5)

  1. To estimate the duration of clinical benefit.

    Measured: 2 years

  2. To estimate the objective tumor response rate (using RECIST best overall response of CR + PR).

    Measured: 2 years

  3. To estimate the duration of tumor response.

    Measured: 2 years

  4. To estimate progression-free survival.

    Measured: 2 years

  5. To estimate time to treatment failure by measuring time to treatment failure (includes disease progression, second primary cancer, death from any cause, or discontinuation of protocol therapy in the absence of disease progression).

    Measured: 2 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 2003
  3. Study completionSep 2006

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
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00052169
Sponsor's protocol ID
NSABP FB-IR-002
Status last verified
Dec 2007
First submitted
24 Jan 2003
Last updated
18 Dec 2007
Results posted
No
Data monitoring committee
No

Publications

  • Dennison SK, Jacobs SA, Wilson JW, Seeger J, Cescon TP, Raymond JM, Geyer CE, Wolmark N, Swain SM. A phase II clinical trial of ZD1839 (Iressa) in combination with docetaxel as first-line treatment in patients with advanced breast cancer. Invest New Drugs. 2007 Dec;25(6):545-51. doi: 10.1007/s10637-007-9055-6. Epub 2007 Jun 12.

    PubMed 17563856

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZD1839 in combination with docetaxel in people with Breast Neoplasms, run by NSABP Foundation Inc 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 31 inclusion and 0 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 18 Dec 2007. 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?

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?

To estimate the clinical benefit rate of the combination of ZD 1839 and docetaxel; clinical benefit measured by clinical response, pathologic response, and stable disease (SD greater than or equal to 24 weeks) (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT00052169, 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 18 Dec 2007.

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