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Sponsors and Collaborators: |
University of Arkansas OSI Pharmaceuticals |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00570258 |
This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progression after first line hormonal therapy.
The measure of efficacy for both primary objectives will be time to progression.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Drug: Fulvestrant Drug: erlotinib Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal Therapy |
Estimated Enrollment: | 130 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
2: Placebo Comparator
Fulvestrant: 250 mg IM Q 4 weeks Placebo: 150 mg PO QD |
Drug: Fulvestrant
250 mg IM Q 4 weeks
Drug: Placebo
Placebo 150 mg PO QD
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1: Active Comparator
Fulvestrant: 250 mg IM Q 4 weeks Erlotinib: 150 mg PO QD |
Drug: Fulvestrant
Fulvestrant: 250 mg IM Q 4 weeks
Drug: erlotinib
150 mg PO QD
|
This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progressed after first line hormonal therapy.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Prior bilateral oophorectomy OR No menstrual period for 12 months or longer. If age 55 years or less and on tamoxifen within the prior 6 months, must have an estradiol level in the postmenopausal range.
Exclusion Criteria:
1. Subjects must not have had more than 1 prior chemotherapy regimen for metastatic disease and no chemotherapy within 3 weeks prior to randomization. 2. No concurrent chemotherapy is allowed while on protocol therapy. Subjects whose adjuvant hormonal therapy was discontinued more than 12 months ago must have had only 1 prior hormonal therapy for metastatic disease. Subjects who relapsed while receiving adjuvant hormonal therapy or less than 12 months after completing adjuvant hormonal therapy may be enrolled directly in the trial.
3. No prior therapy with an estrogen receptor down-regulator (e.g. fulvestrant). Non-protocol concurrent hormonal therapy is not allowed. Subjects must not have had prior therapy with agents that target EGFR. Previous, but not concomitant, therapy with trastuzumab (Herceptin) is allowed. Subjects must not receive trastuzumab (Herceptin) within 3 weeks prior to randomization.
4. Subjects must have ECOG performance status of 0, 1, or 2. 5. Subjects must have adequate hematologic, hepatic, and renal function defined by the following within 4 weeks prior to randomization: Neutrophils > 1500/mm3 and platelets over 100,000/mm3 Total Bilirubin under 1.25 x Institutional upper limit of normal SGPT (ALT) and SGOT (AST) under 2.5 x Institutional upper limit of normal if no demonstrable liver metastases or under 5 x Institutional upper limit of normal in the presence of liver metastases Calculated creatinine clearance over 30ml/min using the following formula: Ccr = (140 - age in years) times (weight in kgs) times 0.085 72 x serum creatinine in mg/dL INR, PT and PTT under 1.5 x Institutional upper limit of normal.
6. Subjects must not be receiving therapy with anticoagulants or have other contraindication to IM injections.
7. Subjects must be age over 18 years. 8. Subjects must not have a history of central nervous system metastasis. 9. Subjects may receive concurrent radiation therapy to painful sites of bony disease or areas of impending fracture as long as the radiation therapy is initiated prior to study entry and sites of measurable disease outside the radiation therapy port are available to follow.
10. Subjects must not take the following medications while enrolled in this trial: ketoconazole, erythromycin, verapamil.
11. Subjects age less than 55 years must not be receiving LHRH agonists or antagonists within 3 months prior to randomization.
12. Subjects who have an ocular inflammation or infection should be fully treated before entry into the trial.
13. Subjects with a neuropathic keratopathy or diabetes or those with anterior basement membrane disease must be advised of the need for frequent ophthalmologic exams.
14. Subjects who continue to wear contact lenses must be advised that they have an increased risk of ocular events. The decision to wear contact lenses should be discussed with the patient's treating oncologist and ophthalmologist.
15. Subjects must not suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities.
16. Subjects must be disease-free of prior invasive malignancies for over 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
Contact: Chris Golden | 501-686-8274 | GoldenChristopherD@uams.edu |
Contact: Sandy Annis | 501-686-8274 | amannis@uams.edu |
United States, Arkansas | |
University of Arkansas for Medical Sciences | Recruiting |
Little Rock, Arkansas, United States, 72205 | |
Contact: Chris Golden 501-686-8274 GoldenChristohperD@uams.edu | |
Contact: Sandy Annis 501-686-8274 amannis@uams.edu | |
Principal Investigator: Issam Makhoul, MD | |
Highlands oncology Group | Recruiting |
Springdale, Arkansas, United States, 72764 | |
Contact: Wendy Pernell 479-872-8130 | |
Principal Investigator: Thadeus Beck, MD | |
NEA Clinic | Recruiting |
Jonesboro, Arkansas, United States, 72401 | |
Contact: Ronald Blachly, MD 870-934-5343 | |
Contact: Dawn Smith, RN 870-934-5343 | |
Principal Investigator: Ronald Blachly, MD | |
United States, Missouri | |
St. Luke's Cancer Institute | Recruiting |
Kansas City, Missouri, United States, 64111 | |
Contact: Teresa Maag 816-932-1601 | |
Principal Investigator: Ali Shwaiki, MD | |
United States, New Jersey | |
Hackensack University | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: George Badin 201-336-8137 | |
Principal Investigator: Stanley Waintraub, MD |
Principal Investigator: | Issam Makhoul, MD | University of Arkansas |
Responsible Party: | University of Arkansas for Medical Sciences ( Issam Makhoul, MD ) |
Study ID Numbers: | UARK 2004-19 |
Study First Received: | December 6, 2007 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00570258 |
Health Authority: | United States: Institutional Review Board |
Erlotinib Skin Diseases Fulvestrant |
Disease Progression Breast Neoplasms Breast Diseases |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses |