Trial ID # | NCT00023907; NCT00191607; Study 30-49; ITSG |
Phase | II/III |
Drug Class | Chemotherapy, Chemotherapy, Chemotherapy, Chemotherapy |
Drug Name | Gemcitabine, Liposomal doxorubicin, Paclitaxel, Topotecan |
Alternate Drug Names | Gemzar, Pegylated Liposomal Doxorubicin Hydrochloride, liposomal doxorubicin, LipoDox, Evacet, Dox-SL, Doxil, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, TXL, Hycamptamine, Hycamtin, TOPO |
Drugs in Trial | Gemcitabine, Liposomal doxorubicin, Paclitaxel, Topotecan |
Eligible Participant | Platinum resistant ovarian cancer |
Therapy Setting | Recurrence |
Endpoints | ORR, PFS, evaluated per RECIST |
Efficacy | 1. International Topotecan Study Group (ITSG) (Phase III, n=226; 120 primary Pt-R or Pt-Rf) 2. Study 30-49 (Phase III, n=474; 256 primary Pt-R or Pt-Rf) 3. NCT00023907 (Phase II, n=51, Pt-R and Pac-R) 4. NCT00191607 (Phase III, n=195; Pt-R with less than or equal to 2 prior therapies) Combined Results: |
Conclusion | Similar response rates for single-agent gemcitabine, liposomal doxorubicin, paclitaxel or topotecan in Pt-R patients |
Reference | 1. Ten Bokkel et al. Topotecan Versus Paclitaxel for the Treatment of Recurrent Epithelial Ovarian Cancer. J Clin Oncol (1997) 15: 2183-93 2. Gordon AN et al. Recurrent Epithelial Ovarian Carcinoma: A Randomized Phase III Study of Pegylated LIposomal Doxorubicin Versus Topotecan. J Clin Oncol (2001) 19(14): 3312-22 3. Markmann M et al. Phase II trial of weekly paclitaxel (80 mg/m2) in platinum and paclitaxel-resistant ovarian and primary peritoneal cancers: a Gynecologic Oncology Group study. Gynecol Oncol (2006) 101(3): 436-40 4. Mutch DG et al. Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol (2007) 25(19): 2811-8 |