Clinical Trial - NCT03144804

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

Recruiting

Sponsor: Massachusetts General Hospital

Collaborators:

Information provided by (Responsible party): Principal Investigator Massachusetts General Hospital Aparna Parikh Principal Investigator

ClinicalTrials.gov Identifier: NCT03144804

Protocol Info

Short Description: Phase 2 of Lamivudine in p53 Mutant Metastatic Colorectal Cancer
Long Description: A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer
MGH Status: Open
Sponsor: DF/HCC
Disease Program: GI

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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 Title Intervention Phase
Colorectal Cancer Metastatic Lamivudine Phase 2
Study Type Interventional
Official Title A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer

Primary Outcome Measures

Overall Response Rate [Time Frame: 2 years] [Designated as safety issue: ]


Secondary Outcome Measures

Progression Free Survival [Time Frame: 2 years] [Designated as safety issue: ]

Overall Survival [Time Frame: 2 years] [Designated as safety issue: ]

Overall Disease Control Rate [Time Frame: 2 years] [Designated as safety issue: ]

Estimated Enrollment: 32
Study Start Date: October 2017
Estimated Study Completion Date: November 2024
Estimated Primary Completion Date: November 2020
Arms Assigned Interventions

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.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03144804

Locations

  • United States, Massachusetts
    • Massachusetts general Hospital Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

More Information

No publications provided

Responsible Party: Principal Investigator Massachusetts General Hospital Aparna Parikh Principal Investigator
ClinicalTrials.gov Identifier: NCT03144804
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Massachusetts General Hospital:

Colorectal Cancer

Additional relevant MeSH terms:

Colorectal Neoplasms

Lamivudine

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on July 18, 2019