- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00966992
Study of Zoledronic Acid Versus Observation on Bone Mineral Density and Incidence of Micrometastasis in Women Undergoing Pelvic Radiation for Cervical Cancer
August 10, 2015 updated by: Washington University School of Medicine
Randomized Phase II Study of Zoledronic Acid vs Observation on Bone Mineral Density and Incidence of Micrometastasis in Women Undergoing Pelvic Radiation for Cervical Cancer
The treatment of cervical cancer with chemotherapy and radiation will make women post menopausal (no estrogen from the ovaries), if a woman is not already in menopause.
Estrogen plays a key role in maintaining bone health.
Therefore, these women are at higher risk of getting osteoporosis (decrease minerals in the bone) and bone fractures.
The overall purpose of this research is to look at the effects of zoledronic acid (Zometa) on preventing bone loss.
Studies have also shown that zoledronic acid may prevent metastasis to the bone which can occur in women with cervical cancer.
Zometa is investigational (not approved by the Food and Drug Administration (FDA)) in this study to prevent metastasis to the bone in women with cervical cancer.
Therefore, the goal of this study is to also look at the effects of zoledronic acid (Zometa) on circulating tumor cells in the bone marrow and blood.
This study is being done to find a way to prevent bone loss and metastasis to the bone in women undergoing chemotherapy and radiation for cervical cancer.
An additional component of the study is to assess the importance of stress on immune markers in blood during standard treatment.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES
- To determine the incidence of disseminated tumor cells (DTCs) in bone marrow and circulating tumor cells (CTCs) in the blood of women with cervical cancer at diagnosis and 3 to 9 months after chemotherapy and pelvic radiation with and without Zometa.
- To determine the change in biochemical markers of bone turnover from diagnosis to 9 months after radiation in women receiving chemoradiation for cervical cancer with and without Zometa.
- To determine change in bone mineral density from diagnosis to 9 month after chemoradiation with and without Zometa.
- To determine if depressed and anxious mood are associated with greater impairment of adaptive immunity (ratio of Th1/Th2) and higher levels of angiogenesis (VEGF) in peripheral blood of cervical cancer patients.
- To examine the relationship of standardized uptake values (SUV)Max and metabolic heterogeneity in the primary tumor and evidence of persistent/recurrent disease on the 3 and 9 month Fludeoxyglucose (FDG)-Positron Emission Tomography (PET) scans with DTCs and CTCs.
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Histologically proven squamous, adenosquamous or adenocarcinoma International Federation of Gynecology and Obstetrics (FIGO) Stage IB-IVA of the uterine cervix undergoing initial radiation and cisplatin based chemotherapy for primary treatment.
- Gynecologic Oncology Group performance status of 0, 1, or 2.
- Patients with ureteral obstruction must undergo stent placement or nephrostomy tube placement prior to study entry.
- Age >= 18 years.
- Patients must have signed informed consent.
Patients must have adequate:
- Bone marrow function: absolute neutrophil count (ANC) greater than or equal to 1,500/ul, equivalent to Common Toxicity Criteria (CTCAE) grade 1. Platelets greater than or equal to 100,000/ul.
- Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal (ULN). If creatinine is greater than 1.5 x ULN, creatinine clearance must be greater than 60 ml/min.
- Hepatic function: bilirubin less than or equal to 1.5 x ULN. AST and alkaline phosphatase less than or equal to 2.5 x ULN.
- Neurologic function: neuropathy (sensory and motor) less than or equal to CTCAE grade 1.
- Coagulation: prothrombin time (PT) such that the international normalized ratio (INR) is < 1.5 (INR may be between 2 and 3 if a patient is on stable dose of therapeutic warfarin) and a PTT < 1.2 times control.
Exclusion Criteria:
- Evidence of sepsis or severe infection.
- Previous or current treatment for osteoporosis. Patients with denovo osteoporosis are also excluded.
- Evidence of bone metastasis.
- Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), or exposed bone in the mouth, or of slow healing after dental procedures.
- Recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction, implants).
- Patients with history of other invasive malignancy (treatment within the last 5 years) other than non-melanoma skin cancer.
- Patients with known hypersensitivity to Zometa or other bisphosphonates.
- Patients who are pregnant or breast feeding.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Arm 1 (No Zometa)
Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation.
All interventions on this arm are standard of care.
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EXPERIMENTAL: Arm 2 (Zometa)
Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation.
Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Circulating Tumor Cells (CTCs)
Time Frame: At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment
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At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment
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Incidence of Disseminated Tumor Cells in Bone Marrow
Time Frame: At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment
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At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Bone Mineral Density
Time Frame: At the time of diagnosis and 9 months after completion of treatment
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At the time of diagnosis and 9 months after completion of treatment
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Change in Biochemical Markers of Bone Turnover
Time Frame: At the time of diagnosis and 9 months after completion of treatment
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At the time of diagnosis and 9 months after completion of treatment
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If Depressed and Anxious Moods Are Associated With Greater Impairment of Adaptive Immunity and Higher Levels of Angiogenesis in Peripheral Blood
Time Frame: At diagnosis, 6 months after completion of treatment, and 9 months after completion of treatment
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At diagnosis, 6 months after completion of treatment, and 9 months after completion of treatment
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Relationship of SUVmax and Metabolic Heterogeneity in the Primary Tumor and Evidence of Persistent/Recurrent Disease
Time Frame: 3 months after completion of treatment and 9 months after completion of treatment
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3 months after completion of treatment and 9 months after completion of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (ACTUAL)
March 1, 2010
Study Completion (ACTUAL)
March 1, 2010
Study Registration Dates
First Submitted
August 18, 2009
First Submitted That Met QC Criteria
August 26, 2009
First Posted (ESTIMATE)
August 27, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 9, 2015
Last Update Submitted That Met QC Criteria
August 10, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Neoplastic Processes
- Neoplasm Metastasis
- Uterine Cervical Neoplasms
- Neoplasm Micrometastasis
- Physiological Effects of Drugs
- Bone Density Conservation Agents
- Zoledronic Acid
Other Study ID Numbers
- 09-0811
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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