Compilation of multiple single drug chemotherapy trials for platinum-resistant recurrence

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)
Pac vs Top:
ORR: 7 vs 13%

2. Study 30-49 (Phase III, n=474; 256 primary Pt-R or Pt-Rf)
PLD vs Top:
ORR: 12.3 vs 6.5%
PFS: 2.3 vs 3.4 months

3. NCT00023907 (Phase II, n=51, Pt-R and Pac-R)
Weekly Pac:
ORR: 20.9%

4. NCT00191607 (Phase III, n=195; Pt-R with less than or equal to 2 prior therapies)
Gem vs PLD:
ORR: 8.3 vs 6.1%
PFS: 3.1 vs 3.6 months

Combined Results:
ORR: median 8% (6.1-20.9%)
PFS: median 3.3 months (2.3-4.3 months)

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
https://www.ncbi.nlm.nih.gov/pubmed/9196130

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
https://www.ncbi.nlm.nih.gov/pubmed/11454878

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
https://www.ncbi.nlm.nih.gov/pubmed/16325893

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
https://www.ncbi.nlm.nih.gov/pubmed/17602086

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