Table 2.
A summary of ongoing large clinical trials evaluating the use of Zoledronic acid in different cancers.
| Study name | Patient population | Study design and treatment | Primary endpoints | References |
|---|---|---|---|---|
| NATAN | 654 BC patients | Standard therapy +/− | EFS at 5 y | ClinicaTrials.gov No. NCT00512993 |
| ZA (4 mg IV q1mo; q3mo; q6mo) | German Breast Group | |||
| SUCCESS | 3754 BC patients (stages I, II, and IIIA) | FEC/DOC +/− GEM, then endocrine therapy plus ZA for 2 y or 5 y | DFS at 5 y | The SUCCESS Study Group 2009 |
| www.Success-studie.de | ||||
| SWOG 0307 | 5400 BC patients (stages I, II, and IIIA) | ZA (4 mg q1mo; q3mo); CLO (1600 mg/d); IBN (50 mg/d) | DFS and OS up to 10 y | ClinicTrials.gov No. NCT00127205 |
| Southwest Oncology Group | ||||
| ZEUS | 1498 PC patients (high-risk, early) | Standard therapy +/− ZA (4 mg IV q3mo) | EFS at 4 y | Register no. 66626762 〈http://www.controlled-trials.com/〉 |
| European Association of Urology | ||||
| RADAR | 1071 PC (stage T2b-4) | ADT for 6 mo or 18 mo +/− ZA (4 mg IV q3mo) | PSA-RFS at 18 mo | ClinicalTrials.gov No. NCT00193856 |
| Trans-Tasman Radiation Oncology Group | ||||
| STAMPEDE | 3300 PC patients (high risk) | ADT and (1) no additional therapy; (2) DOC (q3wk); (3) celecoxib (BID); (4) ZA (q3wk; q4wk); (5) DOC+ZOL; (6) celecoxib+ZA | FFS and OS (multiple phases) | ClinicalTrials.gov Identifier, NCT00268476 |
| Medical Research Council | ||||
| Study 2419 | 446 NSCLC patients (stage IIIA or IIIB) | ZA (4 mg IV q1mo) | TTP | ClinicalTrials.gov Identifier NCT00172042 |
| Novartis 2009 | ||||
| CALGB 90202 | 680 pts with met PrCa on ADT | ZA 4 mg IV every month versus placebo | PFS and OS | ClinicalTrials.gov Identifier: NCT00079001 |
BC indicates breast cancer; IBN, ibandronate; IV, intravenous; q4wk, every 4 weeks; +/−, with or without; DFS, disease-free survival; FEC, combined 5-flurouracil, epirubicin, and cyclophosphamide; DOC, docetaxel; ZA, zoledronic acid; EFS, event-free survival; q1mo, monthly; q3mo, every 3 months; GEM, gemcitabine; OS, overall survival; CLO, clodronate; PC, prostate cancer; ADT, androgen-deprivation therapy; PSA-RFS, prostate-specific antigen recurrence-free survival; BID, twice daily; FFS, failure free survival; NSCLC, non-small cell lung cancer; TTP, time to progression.