Brief Title
Lenvatinib and Weekly Paclitaxel for Patients With Recurrent Endometrial or Ovarian Cancer
Official Title
Phase I Evaluation of Lenvatinib and Weekly Paclitaxel in Patients With Recurrent Endometrial, Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the recommended phase II dose (RPTD) of combination lenvatinib mesylate
(lenvatinib) and weekly paclitaxel in patients with recurrent endometrial, epithelial
ovarian, primary peritoneal, or fallopian tube carcinoma.
SECONDARY OBJECTIVES:
I. To determine the safety and tolerability of combination lenvatinib and weekly paclitaxel
in patients with recurrent endometrial, epithelial ovarian, primary peritoneal, or fallopian
tube carcinoma.
II. To explore the objective antitumor activity (complete and partial response) of
combination lenvatinib and weekly paclitaxel as measured by Response Evaluation Criteria in
Solid Tumors (RECIST) criteria.
III. To measure the progression free survival. IV. To evaluate the pharmacokinetics of
combination paclitaxel and lenvatinib.
OUTLINE: This is a dose -escalation study of lenvatinib mesylate.
Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15 and
lenvatinib mesylate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 3 months for 3 years.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
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
Secondary Outcome
Objective antitumor activity (complete and partial response) assessed by RECIST criteria
Condition
Fallopian Tube Carcinoma
Intervention
Lenvatinib Mesylate
Study Arms / Comparison Groups
Treatment (lenvatinib, paclitaxel)
Description: Patients 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
26
Start Date
May 27, 2016
Completion Date
November 30, 2019
Primary Completion Date
November 30, 2019
Eligibility Criteria
Inclusion Criteria:
- 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
- Patients who have a history of deep vein thrombosis (DVT) or pulmonary embolus and are
stable on anticoagulation for > 1 month are eligible
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Floor Backes, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02788708
Organization ID
OSU-15273
Secondary IDs
NCI-2016-00256
Responsible Party
Sponsor-Investigator
Study Sponsor
Floor Backes
Collaborators
Eisai Inc.
Study Sponsor
Floor Backes, MD, Principal Investigator, Ohio State University Comprehensive Cancer Center
Verification Date
January 2019