Clinical trial NCT02065687: Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer
Official title: A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer
Conditions: Endometrial Adenocarcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Endometrial Undifferentiated Carcinoma
Recurrent Uterine Corpus Carcinoma
Stage III Uterine Corpus Cancer AJCC v7
Stage IIIA Uterine Corpus Cancer AJCC v7
Stage IIIB Uterine Corpus Cancer AJCC v7
Stage IIIC Uterine Corpus Cancer AJCC v7
Stage IV Uterine Corpus Cancer AJCC v7
Stage IVA Uterine Corpus Cancer AJCC v7
Stage IVB Uterine Corpus Cancer AJCC v7
Summary: This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin is more effective with or without metformin hydrochloride in treating endometrial cancer.
Interventions:
description: Given IV
name: Carboplatin
other_name: Blastocarb
CBDCA
Carboplat
Carboplatin Hexal
Carboplatino
Carboplatinum
Carbosin
Carbosol
Carbotec
Displata
Ercar
JM-8
Nealorin
Novoplatinum
Paraplatin
Paraplatin AQ
Paraplatine
Platinwas
Ribocarbo
type: Drug
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
description: Given PO
name: Metformin Hydrochloride
other_name: APO-Metformin
Cidophage
Dimefor
Glifage
Glucoformin
Glucophage
Glucophage ER
Metformin HCl
Riomet
Siofor
type: Drug
description: Given IV
name: Paclitaxel
other_name: Anzatax
Asotax
Bristaxol
Praxel
Taxol
Taxol Konzentrat
type: Drug
description: Given PO
name: Placebo Administration
type: Other
description: Ancillary studies
name: Quality-of-Life Assessment
other_name: Quality of Life Assessment
type: Other
description: Ancillary studies
name: Questionnaire Administration
type: Other
Study arms:
design_group_description: Patients receive paclitaxel IV over 3 hours on day 1, carboplatin IV over 30 minutes on day 1, and metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.<br/>In both arms, patients who achieve SD or PR and still have measurable disease at the completion of course 6 may continue to receive paclitaxel IV and carboplatin IV (with metformin hydrochloride or placebo) for an additional 4 courses at the discretion of the treating investigator.
design_group_title: Arm I (paclitaxel, carboplatin, metformin hydrochloride)
design_group_type: Experimental
design_group_description: Patients receive paclitaxel IV and carboplatin IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.<br/>In both arms, patients who achieve SD or PR and still have measurable disease at the completion of course 6 may continue to receive paclitaxel IV and carboplatin IV (with metformin hydrochloride or placebo) for an additional 4 courses at the discretion of the treating investigator.
design_group_title: Arm II (paclitaxel, carboplatin, placebo)
design_group_type: Active Comparator
Sponsor: The Gynecologic Oncology Group
Collaborators: National Cancer Institute
Drug name mappings:
name: 卡铂
lang: CN
name: Carboplatin
lang: EN
name: カルボプラチン
lang: JP
name: 盐酸二甲双胍
lang: CN
name: Metformin Hydrochloride
lang: EN
name: メトホルミン塩酸塩
lang: JP
name: 紫杉醇
lang: CN
name: Paclitaxel
lang: EN
name: パクリタキセル
lang: JP