Endometrial Cancer Clinical Trial
Official title:
Randomized Trial Of Adriamycin (A) Cisplatin (P) Chemotherapy Versus Paclitaxel (T) Adriamycin (A) And Cisplatin (P) In Patients With Metastatic/Relapsed Or Locally Advanced Inoperable Endometrial Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
dividing so they stop growing or die. Combining more than one drug may kill more tumor
cells. It is not yet known whether doxorubicin and cisplatin are more effective with or
without paclitaxel in treating endometrial cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of combining doxorubicin and
cisplatin with or without paclitaxel in treating patients who have locally advanced,
metastatic, and/or relapsed endometrial cancer.
OBJECTIVES:
- Compare the overall survival of patients with locally advanced, metastatic, and/or
relapsed endometrial cancer treated with doxorubicin and cisplatin with or without
paclitaxel.
- Compare the toxicity of these regimens in these patients.
- Compare the progression-free survival at 18 months of patients treated with these
regimens.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to performance status (0 vs 1 vs 2), metastatic disease (M0 vs M1), prior pelvic
radiotherapy for pelvic recurrence (yes vs no), and participating center. Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin IV over 30 minutes, paclitaxel IV over 3 hours, and
cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses
in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive doxorubicin and cisplatin as in arm I. Quality of life is
assessed at baseline, before each course, after courses 3 and 6, every 3 months for 2
years, every 6 months for 3 years, and then annually thereafter. In the event of
progressive disease, quality of life is assessed every 3 months.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter. In the event of progressive disease, patients are followed every 3
months.
PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05796518 -
Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
|
N/A | |
| Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06463028 -
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced/Recurrent Endometrial Cancer
|
Phase 2 | |
| Recruiting |
NCT06036836 -
Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)
|
Phase 2 | |
| Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
| Completed |
NCT03820024 -
MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback
|
N/A | |
| Active, not recruiting |
NCT05082025 -
Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT00587886 -
Estrogen, Diet, Genetics and Endometrial Cancer
|
||
| Completed |
NCT05378152 -
Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity
|
N/A | |
| Suspended |
NCT05124743 -
HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
|
||
| Recruiting |
NCT03876860 -
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
|
N/A | |
| Recruiting |
NCT04569773 -
Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
|
||
| Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
| Not yet recruiting |
NCT05998798 -
Revealing Engagement Patterns Among Endometrial Cancer Patients
|
||
| Not yet recruiting |
NCT06366347 -
ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab
|
Phase 2 | |
| Not yet recruiting |
NCT06073184 -
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
|
Phase 2 | |
| Terminated |
NCT02907073 -
Positron Emission Tomography (PET) Imaging Studies With NIS Reporter
|
Phase 1/Phase 2 | |
| Completed |
NCT02549989 -
Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer
|
Phase 2 |