Subjects with no prior therapy:
Pembrolizumab administered at 200 mg
Paclitaxel administered at 175mg/m2
Carboplatin administered at an AUC of 6
Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose:
Pembrolizumab administered at 200 mg
Paclitaxel administered at 135mg/m2
Carboplatin administered at an AUC of 5

Endometrial Cancer

Endometrial Adenocarcinoma

Pembrolizumab 200 mg will be administered every 3 weeks for all subjects

Pembrolizumab

For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.
Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion.

Paclitaxel

For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes.

Carboplatin

Big Ten Cancer Research Consortium Website

Ironwood Cancer and Research Centers

Northwestern University, Robert H. Lurie Cancer Center

Northwestern Medicine Lake Forest Hospital

Indiana University Melvin and Bren Simon Cancer Center

University of Iowa Hospitals and Clinics

University of Minnesota

Pembro/Carbo/Taxol in Endometrial Cancer

Phase II Study of Pembrolizumab in Combination With Carboplatin and Paclitaxel for Advanced or Recurrent Endometrial Adenocarcinoma

Proportion of confirmed partial response (PR) and complete response (CR) rates per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria for evaluable subjects receiving pembrolizumab in combination with standard carboplatin/paclitaxel therapy.

Proportion of subjects who experience ≥ Grade 3 toxicity according per Common Toxicity Criteria for Adverse Effects (CTCAE) v4 criteria while receiving pembrolizumab in combination with standard carboplatin/paclitaxel therapy

Daniela Matei, MD

Sponsor-Investigator

Merck Sharp & Dohme Corp.

Hoosier Cancer Research Network

Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks

Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks
Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day

Transdermal Estradiol

Sex: Female, Male

Race and Ethnicity Not Collected

0 participants were measured because the study was terminated

Absolute Change in 24 Hour Urinary Calcium Excretion

0 participants were analyzed because the study was terminated

Serum 1,25-dihydroxyvitamin D3

Not available because the study was terminated

Serum Bone Morphogenetic Protein 2

Serum Sclerostin

Serum Estradiol

Serum Total Calcium

Calculated Serum Ionized Calcium

Calculated Tubular Resorption of Calcium

Serum 25 Hydroxyvitamin D

Serum Parathyroid Hormone

Serum Phosphorus

Serum Osteocalcin

Serum Bone-specific Alkaline Phosphatase

Serum C-telopeptides of Type 1 Collagen

It is not available because the study was terminated

Serum Procollagen Type 1 N-terminal Propeptide

Overall Study

Murray J. Favus

Hypercalciuria

Hypercalciuria, Familial Idiopathic

Osteopenia

Osteoporosis

4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day

Transdermal estradiol

The University of Chicago

The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass

University of Chicago

FOSAVANCE (70 mg/2800 IU of alendronate and cholecalciferol) or placebo will be given weekly for 1 years duration

endometrial neoplasms/albumine

Pembro/Carbo/Taxol in Endometrial Cancer

The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass

Bone Health in Gynecologic Cancers-does FOSAVANCE Help?

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