Status:
TERMINATED
Study of Zoledronic Acid Versus Observation on Bone Mineral Density and Incidence of Micrometastasis in Women Undergoing Pelvic Radiation for Cervical Cancer
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Uterine Cervical Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 ma...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00966992
Start Date
August 1 2009
End Date
March 1 2010
Last Update
September 9 2015
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110