Pembro/Carbo/Taxol in Endometrial Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02549209|
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Endometrial Adenocarcinoma||Drug: Pembrolizumab Drug: Paclitaxel Drug: Carboplatin||Phase 2|
Hide Detailed Description
OUTLINE: This is a multi-center study.
To ensure the safety of this combination treatment, an initial safety run-in will be conducted for the first 6 subjects. This initial cohort of 6 subjects will be enrolled and treated with standard doses as described below. Based on toxicity analysis of the initial 6 subjects following completion of 18 weeks of treatment, it will be determined if an extended safety run-in period would be beneficial.
In the absence of receiving any prior therapy, eligible subjects will be treated as follows on D1 of cycles lasting 21 days (3 weeks) for a maximum of 6 cycles:
- Pembrolizumab 200mg will be administered as a 30-minute intravenous (IV) infusion every 3 weeks.
- Paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.
- Carboplatin will be dosed at area under the curve (AUC) of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subjects who have had prior radiotherapy/platinum-based chemotherapy must initiate paclitaxel and carboplatin at the following reduced dose levels if they have had prior external radiotherapy involving the whole pelvis or abdomen or over 50% of their spine, and/or prior platinum-based chemotherapy for this, or any other cancer. Eligible subjects will be treated as follows on Day 1 (D1) of cycles lasting 21 days (3 weeks) for a maximum of 6 cycles:
- Pembrolizumab 200mg administered as a 30-minute intravenous (IV) infusion every 3 weeks.
- Paclitaxel will be dosed at 135mg/m2 and be administered as a 3-hour continuous IV infusion.
- Carboplatin will be dosed at an AUC of 5 and given as an IV infusion in 250ml of D5W over 30 minutes.
Subsequent doses of paclitaxel and carboplatin may be escalated to the higher doses as indicated above, provided these subjects do not exhibit hematologic or nonhematologic toxicity > Grade 1, except alopecia.
The following laboratory values must be obtained within 14 days prior to registration for protocol therapy:
- Hemoglobin (Hgb) > 9 g/dL (without transfusion or erythropoietin (EPO) dependency within 7 days of assessment)
- Platelets > 100 K/mm3
- Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
- Creatinine or measured/calculated creatinine clearance (as calculated by institutional standard) ≤ 1.5 X institutional upper limits of normal (ULN) OR ≥60mL/min for subjects with creatinine levels > 1.5 x institutional ULN
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
- Aspartate aminotransferase (AST), alanine transaminase (ALT) or alkaline phosphatase (ALP) < 2.5 x ULN OR ≤ 5 x ULN for subjects with liver metastases
- Albumin ≥ 2.5 mg/dL
Coagulation (Blood Clotting) Tests:
- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless subject is receiving anti-coagulant therapy as long as partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
- Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless subject is receiving anti-coagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pembrolizumab in Combination With Carboplatin and Paclitaxel for Advanced or Recurrent Endometrial Adenocarcinoma|
|Actual Study Start Date :||August 22, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Investigational Treatment
Subjects with no prior therapy:
Subjects with prior external beam radiation therapy (XRT) and/or platinum-based chemotherapy must initiate paclitaxel and carboplatin at a reduced dose:
Pembrolizumab 200 mg will be administered every 3 weeks for all subjects
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.
Other Name: Taxol®
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.
Other Name: Paraplatin®
- Objective Response Rates (ORR) [ Time Frame: From start of treatment Day 1 (D1) and assessed for a maximum of 18 months ]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.
- Incidence of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From start of treatment D1 and every treatment visit thereafter up to a maximum of 18 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549209
|Contact: Dylan Cregar||317.634.5842 ext firstname.lastname@example.org|
|Contact: Daniela Matei, M.D.||email@example.com|
|United States, Arizona|
|Ironwood Cancer and Research Centers||Recruiting|
|Mesa, Arizona, United States, 85206|
|Contact: Lisa Frick 480-398-7671 firstname.lastname@example.org|
|Principal Investigator: Mario Pineda, MD|
|United States, Illinois|
|Northwestern University, Robert H. Lurie Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Daniela Matei, M.D. 312-695-6180 email@example.com|
|Northwestern Medicine Lake Forest Hospital||Recruiting|
|Lake Forest, Illinois, United States, 60045|
|Contact: Valerie Nelson, MD 847-582-2134 firstname.lastname@example.org|
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Amber Bauchle 317-274-2869 email@example.com|
|Principal Investigator: Jeanne Schilder, MD|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Marian Anderson 319-353-4578 firstname.lastname@example.org|
|Principal Investigator: David Bender, MD|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Erin Zielinski 612-624-0937 email@example.com|
|Principal Investigator: Deanna Teoh, MD|
|Study Chair:||Daniela Matei, M.D.||Big Ten Cancer Research Consortium|