EUCTR2004-001101-10-GB
Active, not recruiting
Not Applicable
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
ovartis Pharmaceuticals UK Ltd0 sites446 target enrollmentFebruary 24, 2005
DrugsZometa
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients with unresectable stage IIIA and IIIB Non small cell lung cancer (NSCLC) without bone metastases
- Sponsor
- ovartis Pharmaceuticals UK Ltd
- Enrollment
- 446
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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