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; GOG-212
Phase	III
Drug Class	Chemotherapy, 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 (0.73-1.00, p=0.055), 0.80 (0.68-0.94, p=0.006) OS: 60.0 vs 56.8 vs 58.3 months, HR: 1.03 (0.86-1.24), 1.10 (0.91-1.31)
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. Phase III Randomized Trial of Maintenance Taxanes Versus Surveillance in Women With Advanced Ovarian/Tubal/Peritoneal Cancer: A Gynecologic Oncology Group 0212:NRG Oncology Study. J Clin Oncol (2022) 40(35):4119-4128 https://pubmed.ncbi.nlm.nih.gov/35759733/