Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
University of Pittsburgh |
---|---|
Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00932152 |
This research study will test whether dual anti-estrogen therapy (anastrozole and fulvestrant) slows the time to when the cancer progresses.
Women invited to participate in this study must be post-menopausal and be 18 years of age or older. The study is being performed on a total of 100 individuals. Of this group, 75 will be in the Treatment Groups using Fulvetrant/Anastrozole with our without bevacizumab and 25 will be in the "Best Supportive Care" groups receiving no treatment or just bevacizumab at the University of Pittsburgh Medical Center.
Condition | Intervention | Phase |
---|---|---|
Advanced Non-Small Cell Lung Cancer Postmenopausal Women |
Drug: fulvestrant (Faslodex) Drug: anastrozole (Arimidex) Drug: Bevacizumab (Avastin) Drug: Best standard of care |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II Randomized Trial of Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-Small Cell Lung Cancer Who Have Received First-Line Platinum-Based Chemotherapy With or Without Bevacizumab |
Estimated Enrollment: | 100 |
Study Start Date: | August 2009 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm B, Group 1:best supportive care only: Active Comparator |
Drug: Best standard of care
Subjects will not receive any chemotherapy for NSCLC nor will they received anti-cancer surgery, immunotherapy, radiotherapy or hormonal therapy. Among the therapies they may take are therapies considered acceptable include, but are not limited to, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral
|
Arm B, Group 2: best supportive care and Bevacizumab: Active Comparator |
Drug: Bevacizumab (Avastin)
Bevacizumab (Avastin) 15 mg/kg IV, every 21 days
Drug: Best standard of care
Subjects will not receive any chemotherapy for NSCLC nor will they received anti-cancer surgery, immunotherapy, radiotherapy or hormonal therapy. Among the therapies they may take are therapies considered acceptable include, but are not limited to, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral
|
Arm A, Group 1: fulvestrant and anastrozole only: Experimental |
Drug: fulvestrant (Faslodex)
Fulvestrant (Faslodex) IM 250 mg monthly after a loading dose of 500 mg on day 1 and 250 mg on day 14 of cycle 1.
Drug: anastrozole (Arimidex)
Anastrozole (Arimidex) 1 mg orally QD
|
Arm A, Group 2: fulvestrant, anastrozole and Bevacizumab: Experimental |
Drug: fulvestrant (Faslodex)
Fulvestrant (Faslodex) IM 250 mg monthly after a loading dose of 500 mg on day 1 and 250 mg on day 14 of cycle 1.
Drug: anastrozole (Arimidex)
Anastrozole (Arimidex) 1 mg orally QD
Drug: Bevacizumab (Avastin)
Bevacizumab (Avastin) 15 mg/kg IV, every 21 days
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Prior bilateral oophorectomy or Age greater than 60 years old Age less than 60 years old and amenorrheic for 12 or more months in the absence of chemotherapy or ovarian suppression with FSH and estradiol in the postmenopausal range.
Documented evidence of a tumor response of CR, PR, or SD. Tumor assessment must occur between Cycle 6 (Day
1) of induction therapy and the date of randomization. Tumor assessment will be per RECIST (Appendix 3) by the treating physician. This response does not have to be confirmed in order for the patient to be randomized; however, unconfirmed responses will be stratified in the stable disease strata. Positron emission tomography (PET) scans and ultrasound may not be used for lesion measurements for response determination.
Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) greater than or equal to 1.0 x109/L, platelets greater than or equal to 75 x109/L, and hemoglobin greater than or equal to 9 g/dL. Hepatic: bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) less than or equal to 2.0 Renal: calculated creatinine clearance (CrCl) ≥45 mL/min based on the standard Cockcroft and Gault formula (Cockcroft and Gault 1976).
Exclusion Criteria:
Contact: Athanassios Argiris, MD | 412-648 6619 | argirisae@upmc.edu |
United States, Pennsylvania | |
University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 |
Responsible Party: | University of Pittsburgh Medical Center ( Athanassios Argiris, MD ) |
Study ID Numbers: | UPCI 08-131 |
Study First Received: | July 1, 2009 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00932152 History of Changes |
Health Authority: | United States: Institutional Review Board |
advanced non-small cell lung cancer postmenopausal bevacizumab fulvestrant anastrozole |
Thoracic Neoplasms Estrogen Antagonists Estrogens Anastrozole Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Fulvestrant Antiemetics Bevacizumab Angiogenesis Inhibitors Hormones |
Carcinoma Estrogen Receptor Modulators Anti-Bacterial Agents Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Analgesics Aromatase Inhibitors Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Anastrozole Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Fulvestrant Hormones, Hormone Substitutes, and Hormone Antagonists Bevacizumab Estrogen Receptor Modulators Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Growth Inhibitors |
Angiogenesis Modulating Agents Aromatase Inhibitors Respiratory Tract Neoplasms Estrogen Antagonists Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Growth Substances Enzyme Inhibitors Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |