„Effect of intravenous Zoledronic Acid on Bone Metabolism given over 4 month in patients with prostate cancer or breast cancer and bone metastasis. A prospective, single-arm multicenter study” (ZoTect) - ZoTect

• Conditions: Patients with prostate or breast cancer with bone metastasis; MedDRA version: 9.1Level: LLTClassification code 10036910Term: Prostate cancer NOS

• Registration Number: EUCTR2005-002132-94-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-23
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

- Histologically proven carcinoma of the prostate with evidence of at least one cancer
related bone lesion with or without hormonal treatment.
- Histologically proven carcinoma of the breast with evidence of at least one cancer
related bone lesion
- Negative pregnancy test at screening in case of child-bearing potential.
- Performance status ECOG 0-2
- Laboratory requirements: a) hepatic function: total bilirubin = 2,5 times the upper-
normal limit of the institution, SGPT, SGOT = 2,5 times the upper-normal limit of the
institution.
- Renal function: creatinine clearance more or equal 30 ml/min
- Normal cardiac function
- Life expectancy more or equal 6 months
- Signed informed consent prior to trial entry
- Patients of more or equal 18 years
- Patients must be accessible for treatment
- Standardized therapy for pre- und postmenopausal women is allowed
- Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must
have elapsed since the completion of surgery, chemotherapy and radiotherapy to
breast or bone.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Prior treatment with bisphosphonates within 6 months before study start, and
during treatment with zoledronic acid
- No presence of at least one cancer-related bone lesion that is detectable on
conventional radiographs of bone or detectable on a bone scan and confirmed by
MRT or CT at screening
- Abnormal renal function as evidenced by
A calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is
calculated using the Cockcroft-Gault formula:

CrCl = [[140-age (years)] x weight (kg)] / [72 x serum creatinine (mg/dL)]
{x 0.85 for female patients}

- Patients with clinically symptomatic brain metastases
- History of diseases with influence on bone metabolism such as Paget´s disease
and primary hyperparathyroidism and with need of treatment for osteoporosis
(defined according to DVO, T-Score =2.5).
- Severe physical or psychological concomitant diseases that expected to impair compliance with the provisions of the study protocol or impair the assessment of
drug of patient safety (clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG)
- Breast feeding or Pregnancy, confirmed by a positive serum hCG laboratory test (> 5 mIU/ml)
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >25 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using one or more medically acceptable methods of contraception.
- Known hypersensitivity to zoledronic acid or other bisphosphonates
- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or more or equal 12.0mg/dl (3.00 mmol/L)
- Known history or present abuse of alcohol or drugs
- Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
- Previous Radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 1 month
- Prior malignancy except basal cell or squamous cell skin cancer or any other cancer from which the patient has been disease-free for more or equal 5 yrs.
- Use of other investigational drugs at the time of enrollment, or within 30 days before enrollment
- 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), of 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess course of bone turn-over markers (PINP, bALP, ICTP and CTX);Secondary Objective: - Relationship between tumour burden/metastatic sites assessed by bone scan<br> Soloway Score (63)) and level of bone markers at study entry<br>- Pain assessment (VAS) and analgesics score <br>- Relationship between Pain and course of bone turn-over markers<br>- Rate of SREs <br>- Relationship between SREs and bone turnover markers <br>- Quality of life questionnaire (EORTC 30) <br>- Course of PSA (Patients with prostate cancer only)<br>- Course of urinary NTX ( in centers where storage at -20°C is possible)<br>- Safety and Tolerability (adverse events (AEs), serious adverse events (SAEs))<br>;Primary end point(s): Assessment of the effect of Zoledronic Acid given every 4 weeks for 4 months on bone metabolism. Assessment will carried out by the course of bone turn-over markers.