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Lenvatinib and Weekly Paclitaxel for Patients With Recurrent Endometrial or Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT02788708•Floor Backes

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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
+6 more criteria

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Key Dates

Start Date

May 27, 2016

Primary Completion Date

December 31, 2021

Completion Date

March 31, 2022

Last Updated

September 19, 2022

Enrollment

ACTUAL participants

Conditions

Fallopian Tube CarcinomaRecurrent Ovarian CancerPrimary Peritoneal CarcinomaRecurrent Endometrial Cancer

Interventions

Lenvatinib Mesylate

DRUG

Paclitaxel

DRUG

Pharmacological Study

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Lenvatinib and Weekly Paclitaxel for Patients With Recurrent Endometrial or Ovarian Cancer

Inclusion Criteria

Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery

An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study

Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer.

Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study

Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation