Study of Zoledronic Acid Versus Observation on Bone Mineral Density and Incidence of Micrometastasis in Women Undergoing Pelvic Radiation for Cervical Cancer
Condition: Uterine Cervical Neoplasms
MeSH terms: Uterine Cervical Neoplasms; Neoplasm Micrometastasis
Intervention: Zoledronic acid
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Uterine Cervical Cancer; Cancer of Cervix; Cervix Cancer

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 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.
    

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.