A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or CT-2103 Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy

Trial ID # NCT00108745
Phase III
Drug Class Chemotherapy
Drug Name Paclitaxel, Paclitaxel Poliglumex
Alternate Drug Names Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, TXL, paclitaxel-polyglutamate polymer, polyglutamate paclitaxel, polyglutamic acid paclitaxel, Poly-L-Glutamic acid-Paclitaxel Conjugate, Xyotax
Drugs in Trial Paclitaxel, Paclitaxel Poliglumex
Eligible Participant

Stage III or IV disease with clinical CR after surgery and first-line platinum-taxane chemotherapy

Patients Enrolled

1,157

Therapy Setting

Maintenance

Study Design

Open-Label, Randomized

Endpoints

PFS, OS, evaluated per RECIST

Efficacy

Pac Poliglu vs Pac vs Placebo:

PFS: 16.3 vs 18.9 vs 13.4 months, HR: 0.85 (0.72-0.995), 0.78 (0.67-0.92)
OS: 60.0 vs 51.3 vs 54.8 months, HR: 0.98 (0.78-1.23), 1.10 (0.88-1.38)

Clinically Significant Adverse Events

Pac Poliglu vs Pac vs Placebo:
Serious AE: none
Grade 2-4 AE: neurologic AEs (46 vs 36 vs 14%), gastrointestinal AEs (20.3 vs 27 vs 11%)

Conclusion

Improved PFS with paclitaxel or paclitaxel poliglumex, no OS difference

Reference

Copeland LJ et al. A phase III trial of maintenance therapy in women with advanced ovarian/fallopian tube/peritoneal cancer after a complete clinical response to first-line therapy: An NRG oncology study. SGO (2017) Scientific Plenary VI: Late Breaking Abstracts
https://www.sgo.org/wp-content/uploads/2017/03/3b_Late-Breaking-Abstracts-Tuesday-March-14-2017.pdf