- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00932152
Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC) (no component of small cell).
- Patients must have stage IIIB (with malignant pleural effusion), stage IV NSCLC (as staged by the AJCC Cancer Staging Manual. 6th ed, appendix 1) or stage IV NSCLC as staged by the new AJCC staging system
- Patients with recurrent NSCLC should have recurred 12 months or more after completion of prior chemotherapy given in the context of curative therapy (chemoradiotherapy or adjuvant therapy) are eligible
- Patients should have been treated with 4 cycles of induction chemotherapy utilizing the following regimens: carboplatin/paclitaxel, carboplatin/gemcitabine, carboplatin/paclitaxel + bevacizumab, carboplatin/gemcitabine + bevacizumab, or carboplatin/pemetrexed +/- bevacizumab, (see Section 3.2 for acceptable doses and schedules) and should have CR, PR, or SD as best response.
- Patients should not have progressed on prior chemotherapy for metastatic or recurrent NSCLC.
Must be postmenopausal female, as defined by the following 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.
- Registration/randomization should be within 6 weeks of beginning of last cycle of chemotherapy
- Documented evidence of a tumor response of CR, PR, or SD. Tumor assessment must occur between Cycle 4 (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
- ECOG performance status 0, 1 or 2.
- At least 18 years of age.
- Adequate organ function, including the following:
Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) greater than or equal to 1.0 x10^9/L, platelets greater than or equal to 75 x10^9/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).
- Prior radiotherapy must be completed at least 3 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
- Signed informed consent document on file.
- Patient compliance and geographic proximity that allow adequate follow up.
- Patient must receive on-study therapy no earlier than 21 days and no later than 42 days from their last cycle (Day 1) of induction therapy.
- Patients must have archival tissue samples. Tumor tissue will be submitted for assessment of ERa, ERb, PR, VEGF and aromatase expression. The patient must also agree to mandatory correlative blood samples at baseline, 5 weeks, 9 weeks, 13 weeks and at the time of progression.
- Cisplatin may be used instead of carboplatin as part of the initial induction chemotherapy regimen, at the discretion of the treating physician investigator. The dose and schedule of cisplatin will be according to the standard of care for patients with stage IIIB with malignant pleural effusion or stage IV NSCLC as staged by the AJCC Cancer Staging Manual, 6th ed, appendix 1, that is equivalent to stage IV NSCLC as staged by the new 7th ed AJCC staging system.
Exclusion Criteria:
- Male gender
- With the exception of those chemotherapies listed as Inclusion criterion (4) No other concomitant biological therapy (e.g. cetuximab) is allowed.
- Have received experimental treatment within the last 30 days at the time of study entry.
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- Concurrent administration of any other antitumor therapy (except arm B, who are allowed to continue with bevacizumab).
- Pregnant or breast feeding.
- Have a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
- Patients with two or more deep vein thromboses, or an active deep vein thrombosis.
- Patients taking hormone replacement therapy or other hormonal therapies
- The International Normalized Ratio (INR) must be < 1.6 within 28 days prior to registration.
- Patients with bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting factor deficiency) or a history of recent history of hemoptysis (1/2 tsp of red blood). Patients on stable long term anticoagulation prior to starting this trial are allowed.
- History of hypersensitivity to active or inactive excipients of fulvestrant (ie castor oil or Mannitol).
- Treatment of NSCLC with squamous cell histology with bevacizumab.
- No progressive Brain or CNS metastases
- No other concurrent anticancer therapy is allowed other than Bevacizumab
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm B, Group 1
Best supportive care only: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support PRN
|
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
Other Names:
|
Active Comparator: Arm B, Group 2
Best supportive care and Bevacizumab 15mg/kg every 21 days
|
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
Other Names:
Bevacizumab (Avastin) 15 mg/kg IV, every 21 days
|
Experimental: Arm A, Group 1
Fulvestrant and anastrozole only
|
Fulvestrant (Faslodex) IM 250 mg monthly after a loading dose of 500 mg on day 1 and 250 mg on day 15 of cycle 1.
Anastrozole (Arimidex) 1 mg orally QD
|
Experimental: Arm A, Group 2
Fulvestrant, anastrozole and Bevacizumab
|
Bevacizumab (Avastin) 15 mg/kg IV, every 21 days
Fulvestrant (Faslodex) IM 250 mg monthly after a loading dose of 500 mg on day 1 and 250 mg on day 15 of cycle 1.
Anastrozole (Arimidex) 1 mg orally QD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To Evaluate the Progression-free Survival.
Time Frame: 1.5 years
|
1.5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To Evaluate the Time to Overall Survival, Time to Progression, and Toxicities
Time Frame: 1.5 years
|
1.5 years
|
To Evaluate the Levels of 17b-estradiol, VEGF, E-selectin, Thrombospondin-1 and IGF-1, and Other Biomarkers in the Plasma.
Time Frame: 1.5 years
|
1.5 years
|
To Evaluate Biomarkers (ERa, ERb, PR, VEGF and Aromatase Expression) in Baseline, Archival Tumor Tissue and Correlate Their Expression With Progression-free Survival, Time to Progression, and Overall Survival.
Time Frame: 1.5 years
|
1.5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Antineoplastic Agents
- Gastrointestinal Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Fulvestrant
- Bevacizumab
- Anti-Bacterial Agents
- Anastrozole
- Analgesics
- Antiemetics
Other Study ID Numbers
- UPCI 08-131
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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