Study on Lenvatinib and Everolimus for Treating Advanced Carcinoid Tumors

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03950609

Provider View

This clinical trial is testing how well the drugs lenvatinib and everolimus work together to treat carcinoid tumors that have spread and cannot be removed by surgery. These drugs may help stop tumor growth by blocking certain enzymes needed for cell growth.

Patient Parameters

Program Overview

This study is exploring the effectiveness of combining two drugs, lenvatinib and everolimus, to treat advanced carcinoid tumors that have spread to other parts of the body and cannot be surgically removed. The goal is to see if these drugs can stop the growth of tumor cells by blocking specific enzymes that help cells grow.

Description

The main goal of this study is to determine how well lenvatinib and everolimus work together in shrinking tumors in patients with advanced carcinoid tumors. Researchers will also look at how long patients can live without the disease getting worse and how safe and tolerable the treatment is.

Patients will take lenvatinib and everolimus by mouth every day for 28 days. This cycle will repeat every 28 days as long as the disease does not progress and side effects are manageable. After finishing the treatment, patients will have a follow-up visit 30 days later to check their health and response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced carcinoid tumors that cannot be removed by surgery.
  • Have tumors that can be measured by scans.
  • Have shown disease progression in the last 12 months.
  • Be able to provide written informed consent.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have completed any previous cancer treatments and recovered from any side effects.
  • Have adequate blood cell counts and organ function as indicated by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception during the study.

Exclusion Criteria

  • Have an allergy to lenvatinib, everolimus, or any of their ingredients.
  • Have known or suspected brain metastases unless stable and not requiring treatment.
  • Have other active cancers or cancers within the last 3 years, except for certain skin cancers or cervical cancer.
  • Have difficulty swallowing pills or have gastrointestinal issues that affect drug absorption.
  • Have active infections like HIV, hepatitis B, or hepatitis C.
  • Have had recent major surgery or radiation therapy and not fully recovered.
  • Have significant heart problems or uncontrolled high blood pressure.
  • Be pregnant or breastfeeding.
  • Be unable or unwilling to comply with the study requirements.
  • Be taking certain medications that may interfere with the study drugs.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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