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Rectal CancerPhase 1NCT02935309

Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma

A Phase 1 study testing Lenvatinib, Capecitabine and External Radiation Therapy (XRT) in people with Rectal Cancer and Rectal Adenocarcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study is designed to see if Capecitabine and Lenvatinib in combination with external radiation therapy are effective in treating locally advanced rectal adenocarcinoma in patients who have not yet had surgery, and what the best dosage is. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer, Rectal Adenocarcinoma
What is being tested?
Lenvatinib, Capecitabine and External Radiation Therapy (XRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
14 Oct 2016to 14 May 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically (archival tissue) confirmed adenocarcinoma of the rectum that begins within 12 cm of the anal verge as determined by sigmoidoscopy and/or colonoscopy with no evidence of distant metastasis.
  • Locally advanced rectal cancer determined by any of the following features: 1.) Fixed or immobile tumor on physical exam and/or; 2.) T3 disease with invasion through the muscularis propria as defined by transrectal ultrasound, CT or MRI; 3.) T4 disease with invasion of adjacent structures such as pelvic sidewall, sacrum, pelvis, bladder and/or prostate as determined appropriate imaging modalities such as ultrasound, CT or MRI; 4.) Any T with + N on CT scan/MRI or transrectal ultrasound.
  • Age equal to or greater than 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  • Adequate bone marrow, liver and renal function.
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least 3 months after the last administration of lenvatinib.
  • Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.

Who cannot join

  • Cardiac disease: Congestive heart failure > class II New York Heart Association (NYHA). Participants must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
  • Previous pelvic irradiation therapy.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
  • Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
  • Active clinically serious infection > CTCAE Grade 2.
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  • Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic, attacks, deep vein thrombosis (DVT) within the past 6 months.
  • Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, or similar agents requiring therapeutic international normalized ration (INR) monitoring. (Treatment with low molecular weight heparin (LMWH) is allowed).
  • Active malignancy except for non-melanoma skin cancer or in situ cervical cancer or treated non-pelvic cancer from which the patient has been continuously disease free more than 3 years.
  • Marked baseline prolongation of QT/QTc interval (QTc interval ≥ 500 msec) using the Fridericia method (QTc = QT/RR0.33) for QTc analysis.
  • Greater than 30 mg/dL on urine analysis. Patients with >30 mg/dL on urine analysis on urine analysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Patients with 24-hour protein ≥1 g/24 hours will be ineligible.
  • Needing medical attention for serious bleeding in past 4 weeks.
  • Previous chemotherapy except for antiangiogenic agent or tyrosine kinase inhibitor (TKI) will be allowed as long as it is more than 5 years.
  • Major surgeries within 3 weeks of starting chemotherapy.
  • Evidence or history of bleeding diathesis.
  • Use of St. John's Wort or rifampin.
  • Known or suspected allergy to lenvatinib or any agent given in the course of this trial.
  • Any condition that impairs participant's ability to swallow whole pills.
  • Any malabsorption problem.
  • Medical need for the continued use of potent inhibitors/inducers of CYP3A4.
  • Creatinine clearance not within study guidelines.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase I Study of Pre-operative Capecitabine and Lenvatinib With External Radiation Therapy in Locally Advanced Rectal Adenocarcinoma

This research study is designed to see if Capecitabine and Lenvatinib in combination with external radiation therapy are effective in treating locally advanced rectal adenocarcinoma in patients who have not yet had surgery, and what the best dosage is.

Being tested
Lenvatinib, Capecitabine, External Radiation Therapy (XRT)
Keywords
rectum, transrectal, carcinoma
Medical subject headings
Rectal Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenvatinibDrug

    Also called E7080

    Pre-surgery Lenvatinib, days 1 - 5. Dose Escalation Levels: 1.) 10 mg by mouth (PO) daily (QD); 2.) 14 mg PO QD; 3.) 20 mg PO QD; 4.) 24 PO QD.

  • CapecitabineDrug

    Also called Teva-Capecitabine, Xeloda

    Pre-surgery Capecitabine, 850 mg/m^2, twice a day (BID) on days 1-5 for 5½ -6 weeks.

  • External Radiation Therapy (XRT)Radiation

    Also called Radiotherapy, Radiation Therapy (RT)

    Pre-surgery RT: Participants will receive 6 weeks of radiation therapy. The radiation sessions will be daily, Monday through Friday, except for holidays.

Study groups in NCT02935309
Study groupRoleWhat they receive
Pre-Surgery Chemotherapy/RadiotherapyExperimentalPre-surgery chemotherapy and external radiation therapy. Dose escalation of Lenvatinib; fixed dose Capecitabine; Radiotherapy. Lenvatinib and capecitabine will be started on day 1 with radiation and will be discontinued on the last day of radiation. Surgical resection should occur between 6 - 10 weeks after the participant completes preoperative lenvatinib, capecitabine, and radiation therapy. Postoperative chemotherapy after surgery will be given at investigator's discretion.
Receives: Drug: Lenvatinib; Drug: Capecitabine; Radiation: External Radiation Therapy (XRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    MTD of lenvatinib used in combination with capecitabine and external beam radiation as neoadjuvant therapy for patients with locally advanced rectal carcinoma. The MTD of lenvatinib will be defined as the highest dose level at which no more than 1 out of 6 participants experiences dose-limiting toxicity (DLT). DLT: Any of the hematology or non-hematologic toxicities noted in Table 3 of the protocol, considered to be at least possibly related to lenvatinib and/or capecitabine.

    Measured: Up to 6 months

Secondary outcomes (2)

  1. Rate of Pathologic Response

    Pathologic response rate after pre-operative therapy and surgery. Pathologic Complete Response (pCR) will be defined as pathologic proof of a complete response based on histologic evaluation of the resected specimen.

    Measured: Up to 36 months

  2. Occurrence of Treatment Related Adverse Events

    To further define safety profile of the combination. Adverse events will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0.

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2016 (estimated)
  2. Study start14 Oct 2016
  3. Primary completion11 Oct 2019
  4. Study completion14 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02935309
Sponsor's protocol ID
MCC-18646
Status last verified
May 2022
First submitted
12 Oct 2016
Last updated
31 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Mehta R, Frakes J, Kim J, Nixon A, Liu Y, Howard L, Martinez Jimenez ME, Carballido E, Imanirad I, Sanchez J, Dessureault S, Xie H, Felder S, Sahin I, Hoffe S, Malafa M, Kim R. Phase I Study of Lenvatinib and Capecitabine with External Radiation Therapy in Locally Advanced Rectal Adenocarcinoma. Oncologist. 2022 Aug 5;27(8):621-e617. doi: 10.1093/oncolo/oyac003.

    PubMed 35325225

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lenvatinib, Capecitabine and External Radiation Therapy (XRT) in people with Rectal Cancer and Rectal Adenocarcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02935309, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.

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