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A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03144804
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Aparna Parikh, Massachusetts General Hospital

Brief Summary:

This research study is studying a drug as a possible treatment for p53 mutant metastatic colorectal cancer.

The drug involved in this study is:

-Lamivudine


Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Drug: Lamivudine Phase 2

Detailed Description:

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved lamivudine for this specific disease but it has been approved for other uses.

In this research study, the investigators are studying the effects of lamivudine on this type of cancer. This drug may help prevent the growth and spread of the cancer cells to other parts of the body. The investigators have discovered that this particular type of colon cancer, which has a p53 mutation may be sensitive to treatment with lamivudine by impairing the ability of the cancer cells to grow.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Lamivudine

Arm Intervention/treatment
Experimental: Lamivudine
  • Lamivudine administered orally every 4 weeks
  • Treatment cycles will last 28 consecutive days
  • The dosage will be determine by the PI
Drug: Lamivudine
This drug may help prevent the growth and spread of the cancer cells to other parts of the body.
Other Name: Combivir




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 years ]
  2. Overall Survival [ Time Frame: 2 years ]
  3. Overall Disease Control Rate [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed adenocarcinoma of the colon that has metastasized (stage 4) and is TP53 mutant/deleted by a CLIA approved genetic test. Only known loss of function TP53 mutation/deletion will be eligible for this study.
  • Participants must have measureable disease, defined as at least on 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 > 20mm with conventional techniques or > 10 mm with spiral CT scan, MRI or calipers by clinical exam. See section 11 for evaluation of measurable disease
  • Patients must be resistant to or intolerant of 5FU, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab (if RAS wild type)
  • Age 18 or older.
  • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
  • Life expectancy of greater than 8 weeks.
  • Participants must have normal organ and marrow function as defined below:

    • absolute neutrophil count ≥1,200/mcL
    • platelets ≥75,000/mcL
    • total bilirubin ≤1.5 × institutional upper limit of normal within normal
    • AST(SGOT)/ALT(SGPT) ≤5 × institutional upper limit of normal
    • creatinine within normal institutional limits OR
    • creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
  • The effects of lamivudine on the developing human fetus are known to be teratogenic. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of lamivudine administration.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Participants who are receiving any other investigational agents.
  • Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to lamivudine.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because lamivudine is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lamivudine, breastfeeding should be discontinued if the mother is treated with lamivudine.
  • HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with lamivudine
  • HBV positive participants will be excluded given the known effects of lamivudine on HBV.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144804


Contacts
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Contact: Aparna R Parikh, MD 617-724-4000 Aparna.Parikh@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts general Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Aparna R. Parikh, MD    617-724-4000    Aparna.Parikh@mgh.harvard.edu   
Principal Investigator: Aparna R. Parikh, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Aparna R. Parikh, MD Massachusetts General Hospital

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Responsible Party: Aparna Parikh, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03144804     History of Changes
Other Study ID Numbers: 17-044
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Aparna Parikh, Massachusetts General Hospital:
Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents