A Study of Tucatinib and Trastuzumab in People With Rectal Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

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