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Therapy with docetaxel and ZD1839 for Patients who have advanced breast cancer



Therapy with docetaxel and ZD1839 for Patients who have advanced breast cancer

For Condition: Breast Neoplasms
Status: Recruiting
Sponsor(s): National Surgical Adjuvant Breast and Bowel Project (NSABP) , AstraZeneca
Synopsis: The purpose of this study is to learn how breast cancer tumors respond to treatment combining the drugs docetaxel and ZD1839.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - 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 - 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 Critera - 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
Total Enrollment: 49

Location and Contact Information:

NSABP Operations Center *Recruiting*
Pittsburgh,  Pennsylvania,  15212
United States
Recruiting Judith  Negley 412-330-4655


Additional Information:
Study ID Numbers:  NSABP FB-IR-002; 
Study Start Date: January 2003
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052169

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3. A Multimodality Treatment Approach to Patients with Inflammatory Cancer of the Breast and Locally Advanced Non-Inflammatory Stage III Breast Cancer and Stage IV Breast Cancer

4. Breast Neoplasms Study

5. Comparison of Nolvadex 20 mg and placebo combination to Nolvadex 20 mg and ZD1839 (IRESSA™) 250 mg combination in patients with metastatic breast cancer and estrogen receptor (ER) and/or progesterone (PR) positive tumours

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