Phase I Evaluation of Lenvatinib and Weekly Paclitaxel in Patients With Recurrent Endometrial, Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Trial ID # NCT02788708
Phase I
Drug Class Angiogenesis Inhibitors: Multi-targeted RTK
Drug Name Lenvatinib
Alternate Drug Names MK-7902, Lenvima, ER-203492-00, E7080
Drugs in Trial Paclitaxel, Lenvatinib
Eligible Participant

Platinum resistant ovarian cancer or recurrent endometrial cancer

Patients Enrolled

26 [19 ovarian: 14 high-grade serous, 1 low-grade serous, 2 clear cell, 1 endometrioid, and 1 carcinosarcoma; median 3 prior therapies (1-5)]

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DoR, PFS, RP2D, evaluated per RECIST

Efficacy

RP2D: 16 mg of lenvatinib with 80 mg/m2 paclitaxel weekly
ORR (OvCa): 71% (incl. 1 LGS for 33+ months, 2 clear cell, 1 carcinosarcoma)
DoR: 8.2 months
PFS (OvCa): 7.2 months

Clinically Significant Adverse Events

Serious AE: one bowel perforation
Grade 3-4 AE: hypertension (27%), anemia (19%), lymphopenia (19%), neutropenia (19%), leukopenia (15%), diarrhea (12%)

Conclusion

Lenvatinib+weekly paclitaxel shows promising response rates in platinum resistant ovarian cancer, also in patients with rare histologies

Reference

Backes FJ et al. Phase I evaluation of lenvatinib and weekly paclitaxel in patients with recurrent endometrial, ovarian, fallopian tube, or primary peritoneal Cancer. Gynecol Oncol (2021) 162(3):619-625
https://pubmed.ncbi.nlm.nih.gov/34272090/

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