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

NCT00966992 | Terminated Phase 2 Results

• 1 other identifier: 09-0811
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Uterine Cervical Neoplasms

Keywords

Uterine Cervical Cancer; Cancer of Cervix; Cervix Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of Circulating Tumor Cells (CTCs)

  At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment

• Incidence of Disseminated Tumor Cells in Bone Marrow

  At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment

Secondary Outcomes (4)

• Change in Bone Mineral Density

  At the time of diagnosis and 9 months after completion of treatment

• Change in Biochemical Markers of Bone Turnover

  At the time of diagnosis and 9 months after completion of treatment

• If Depressed and Anxious Moods Are Associated With Greater Impairment of Adaptive Immunity and Higher Levels of Angiogenesis in Peripheral Blood

  At diagnosis, 6 months after completion of treatment, and 9 months after completion of treatment

• Relationship of SUVmax and Metabolic Heterogeneity in the Primary Tumor and Evidence of Persistent/Recurrent Disease

  3 months after completion of treatment and 9 months after completion of treatment

Study Arms (2)

Arm 1 (No Zometa)

NO INTERVENTION

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.

Arm 2 (Zometa)

EXPERIMENTAL

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.

Drug: Zoledronic acid

Interventions

Zoledronic acid DRUG

Also known as: Zometa

Arm 2 (Zometa)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Perry Grigsby, M.D.
• Organization: Washington University School of Medicine

pgrigsby@radonc.wustl.edu

314-362-8502

Study Officials

• Perry Grigsby, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 27, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 9, 2015
• Results First Posted: September 9, 2015

Record last verified: 2015-08

Locations

US (1)