Recurrent Endometrial Cancer Clinical Trial
Official title:
A Phase I Study of Lapatinib (Tykerb) Plus Ixabepilone (Ixempra) as 2nd-line Treatment for Patients With HER-2 Overexpressed Recurrent or Persistent Endometrial Carcinoma or Carcinosarcoma
Endometrial cancer (EC) is the 8th most common female cancer in Taiwan. Its incidence is
increasing in the recent few years, around 1,200 new cases per year. The outcome of
recurrent EC is disappointing, except focal recurrences that could be irradiated or removed.
Chemotherapy is currently the most common salvage treatment for recurrent endometrial
cancer. However, the response rate (RR) to 2nd-line treatment is approximately 0-27.3%, with
short median time to progression, 2-3.9 months and low overall survival, 6.4-11 months.
Due to progress of studies on the molecular and genetic basis of cancer and cellular
signaling pathways, targeted therapy has been developed for various cancer treatments. A
Gynecologic Oncology Group study found 44% of advanced endometrial cancer had HER>=2+ and
the ratio of HER2:chromosome 17 (CEP17) >=2. Another study showed that HER>=2+ was seen in
47% of carcinosarcoma. These evidences indicated HER2 gene amplification and HER2
overexpression occur in endometrial cancer and carcinosarcoma, especially in those of high
grade and recurrence. Lapatinib (L), an oral inhibitor of both EGFR(epidermal growth factor
receptor) and HER2(human epidermal growth receptor), has been shown to be an effective
treatment in HER2/neu overexpressing metastatic breast cancer. Ixabepilone is a
semisynthetic analog of the natural product epothilone B, and recently has been approved by
US Food and Drug Administration as a treatment option in metastatic breast cancer. It was
also observed that lapatinib + ixabepilone killed more breast tumor cells than trastuzumab +
paclitaxel in vitro. Two GOG(Gynecologic Oncology Group) studies had reported that weekly
Ixabepilone as 2nd-line chemotherapy provided a similar RR to 3-weekly regimen of 14.3% in
platinum- and taxane-resistant epithelial ovarian cancer with less severe toxicities. The
combination of lapatinib and ixabepilone is expected to become an effective treatment for
recurrent endometrial cancer and carcinosarcoma, but the ideal dose is yet to be surveyed.
Patients receive weekly Ixabepilone 32 mg/m2 (D1) and a 4-level of oral Lapatinib 500-1250 mg once daily continuously. The recommended duration of treatment for each patient 21 days a cycle of total 6 cycles or until disease progression, or unacceptable toxicity or patient's refusal occurred. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT05419817 -
Pembrolizumab With Sitravatinib in Recurrent Endometrial Cancer and Other Solid Tumors With Deficient Mismatch Repair System
|
Phase 2 | |
Recruiting |
NCT05798611 -
Study of ART0380 in Patients With Biologically Selected Solid Tumors
|
Phase 2 | |
Completed |
NCT02755844 -
Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Endometrial Cancer Patients
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06366347 -
ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab
|
Phase 2 | |
Active, not recruiting |
NCT02899793 -
Pembrolizumab in Ultramutated and Hypermutated Endometrial Cancer
|
Phase 2 | |
Completed |
NCT02549989 -
Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer
|
Phase 2 | |
Completed |
NCT02788708 -
Lenvatinib and Weekly Paclitaxel for Patients With Recurrent Endometrial or Ovarian Cancer
|
Phase 1 | |
Recruiting |
NCT03564340 -
Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
|
Phase 1/Phase 2 | |
Terminated |
NCT03277482 -
Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer
|
Phase 1 | |
Terminated |
NCT04906382 -
Tislelizumab for the Treatment of Recurrent Mismatch Repair Deficient Endometrial Cancer
|
Early Phase 1 | |
Withdrawn |
NCT02117817 -
Phase I BKM120/Abraxane in Solid Tumors, Expansion Phase Recurrent Endometrial or Ovarian Cancer
|
Phase 1 | |
Withdrawn |
NCT04197219 -
Pembrolizumab With Axitinib in Recurrent Endometrial Cancer
|
Phase 2 | |
Active, not recruiting |
NCT05263492 -
Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer
|
Phase 2 |