About this trial

The study researchers believe that a combination of the drugs trastuzumab and tucatinib, given with standard chemotherapy (capecitabine and oxaliplatin/FOLFOX), may help participants with rectal cancer.

Eligibility criteria

Qualifiers

Willing and able to provide written informed consent for the trial.

Be ≥18 years of age on the date of signing informed consent.

ECOG performance status of 0 or 1.

Histologically confirmed rectal adenocarcinoma.

Disqualifiers

Recurrent rectal cancer.

Prior pelvic radiation therapy, chemotherapy, or surgery for rectal cancer.

Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).

Other invasive malignancy ≤ 5 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.

Trial design

Treatments tested in this trial

  • Trastuzumab
  • Tucatinib

Treatment groups

37 Participants
are divided into 1 treatment group

Locations

7
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920, Basking RidgeNew Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748, MiddletownNew Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645, MontvaleNew Jersey, United States
Memorial Sloan Kettering Cancer Center at Suffolk - Commack (Limited Protocol Activities)11725, CommackNew York, United States

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor