A prospective, multicenter, randomized phase III study to evaluate the efficacy of Zometa (zoledronic acid) in delaying of progression or recurrences in patients with stage III non-small cell lung cancer
- Conditions
- Patients with unresectable stage IIIA and IIIB Non small cell lung cancer (NSCLC) without bone metastases
- Registration Number
- EUCTR2004-001101-10-GB
- Lead Sponsor
- ovartis Pharmaceuticals UK Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 446
• Age = 18 years
• Histologically or cytologically confirmed NSCLC(squamous cell carcinoma, adenocarcinoma, large cell carcinoma) NOTE: Mixed tumors with small cell carcinoma and aplastic carcinoma are not eligible
• Stage IIIA and Stage IIIB at diagnosis excluding patients with pleural effusion at the time of randomisation
• Patients must hve received the primary treatment for their disease and no progression should have occured
•Life expectancy of at least 6 months
• ECOG performance status of 0 or 1
• Weight loss = 10% in the 6 months before diagnosis of NSCLC
• Women of childbearing potential must use a medically acceptable form of contraception during the study and must have a negative urine or serum pregnancy test within 7 days of randomisation.
• Adequate bone marrow reserve defined as white blood cell (WBC) = 3500mm3,
neutrophils = 1500 mm3, platelets = 100,000 mm3, Hb = 9 g/dL
• Able and willing to sign informed consent
•Patients must have recovered from previous thoracotomy
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
• Patients with NSCLC with pleural effusion at the time of randomisation
• Patients who received any prior bisphosphonates in past 12 months
• Presence of metastasis
• Patients with current malignancy within past 5 years other than NSCLC (exceptions
include treated melanoma, ductal carcinoma in situ of the cervix or other cancer cured by resection alone)
• Thoracotomy = 3 weeks prior to randomization
•More than 8 months from the start of the primary antitumour treatment
• Patients with abnormal renal function as evidenced by a calculated creatine clearance < 30ml/minute
• Current active dental problems including infection of the teech or jawbone (maximilla or mandibular); dental or fixed 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)
• Corrected serum calcium < 8.0 mg/dL
• Known hypersensitivity to Zometa or other bisphosphonates
• Patients with nonmalignant conditions which would confound the evaluation of the
primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol,
including:
- Uncontrolled infections
- Uncontrolled Type 2 Diabetes Mellitus
- Diseases with influence on bone metabolism such as Paget’s disease or uncontrolled thyroid or parathyroid dysfunction
- Cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which
would prevent prolonged follow-up
• Patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study
•Patients in whom the primary antitumor treatment is still ongoing
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method