Study of Zoledronic Acid Versus Observation on Bone Mineral Density and Incidence of Micrometastasis in Women Undergoing Pelvic Radiation for Cervical Cancer

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Aug 26, 2009

Keywords

ClinConnect Summary

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 depresse...

Gender

FEMALE

Eligibility criteria

• 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.