Lenvatinib and Weekly Paclitaxel for Patients With Recurrent Endometrial or Ovarian Cancer
Phase I Evaluation of Lenvatinib and Weekly Paclitaxel in Patients With Recurrent Endometrial, Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
2 other identifiers
interventional
26
1 country
1
Brief Summary
This phase I trial studies the side effects and best dose of lenvatinib mesylate when given together with paclitaxel in treating patients with endometrial, ovarian, fallopian tube, or primary peritoneal cancer that has come back or grown. Lenvatinib mesylate may stop the growth of tumor cells by blocking a protein needed for cell growth and may block the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as paclitaxel, 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. Giving lenvatinib mesylate and paclitaxel together may work better in treating patients with endometrial, ovarian, fallopian tube, or primary peritoneal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2016
CompletedStudy Start
First participant enrolled
May 27, 2016
CompletedFirst Posted
Study publicly available on registry
June 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedSeptember 19, 2022
September 1, 2022
5.6 years
April 4, 2016
September 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose (MTD) of lenvatinib mesylate when given with paclitaxel defined as the highest dose level with =< 1 dose limiting toxicities among 6 patients graded by CTCAE
4 weeks
Secondary Outcomes (3)
Objective antitumor activity (complete and partial response) assessed by RECIST criteria
Up to 5 years
Pharmacokinetics (PK) of combination paclitaxel and lenvatinib mesylate
Cycle 1 Day 1 and Day 15 (cycle is 28 days).
Progression free survival
months
Study Arms (1)
Treatment (lenvatinib, paclitaxel)
EXPERIMENTALPatients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and lenvatinib mesylate PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Given IV
Eligibility Criteria
You may qualify if:
- Women with histologically confirmed endometrial cancer, epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (all histological subtypes)who have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to prior treatment
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm with conventional techniques or as ≥10 mm with spiral computerized tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
- Patients must have received prior treatment with a platinum containing regimen and may have received an unlimited number of prior regimens (including prior taxanes)
- Patients with ovarian, Fallopian tube or primary peritoneal cancer must be platinum resistant (progression \< 6 months after completion of a platinum containing regimen)
- Patients may have received prior targeted therapy such as bevacizumab
- Eastern Cooperative Oncology Group performance status =\< 1
- Leukocytes \>= 3,000/mcL (microliter)
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Hemoglobin \>=8.0 g/dL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 × institutional upper limit of normal
- Creatinine \< 1.5 mg/dL X ULN OR creatinine clearance \>= 30 mL/min for patients with creatinine levels above institutional normal
- Urine protein by dipstick \<1+ or UPC =\< 1.0 by urinalysis
- Patients with chronic hypertension that is well controlled with systolic blood pressure of \< 140 mmHg or diastolic blood pressure of \< 90 mmHg, and in whom there has been no change in blood pressure medication in the last two weeks, are eligible
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Floor Backeslead
- Eisai Inc.collaborator
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Floor Backes, MD
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 4, 2016
First Posted
June 2, 2016
Study Start
May 27, 2016
Primary Completion
December 31, 2021
Study Completion
March 31, 2022
Last Updated
September 19, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share