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
18 Years
N/A
Female
Uterine Cervical Neoplasms
Trial Information
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
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 SUVMax and metabolic heterogeneity in the primary tumor
and evidence of persistent/recurrent disease on the 3 and 9 month FDG-PET scans with
DTCs and CTCs.
Inclusion Criteria:
- Histologically proven squamous, adenosquamous or adenocarcinoma 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
FDG-PET Metabolic Response
Outcome Time Frame:
Assessed qualitatively, at 3 and 9 months.
Safety Issue:
No
Principal Investigator
Perry Grigsby, M.D., M.S., M.B.A
Investigator Role:
Principal Investigator
Investigator Affiliation:
Washington University School of Medicine
Authority:
United States: Food and Drug Administration
Study ID:
09-0811
NCT ID:
NCT00966992
Start Date:
August 2009
Completion Date:
Related Keywords:
- Uterine Cervical Neoplasms
- Uterine Cervical Cancer
- Cancer of Cervix
- Cervix Cancer
- Neoplasms
- Uterine Cervical Neoplasms
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