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Clinical Trial Summary

This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cetuximab and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trastuzumab and pertuzumab may work better compared to cetuximab and irinotecan hydrochloride in treating patients with colorectal cancer.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of trastuzumab and pertuzumab (TP) (Arm 1) in HER-2 amplified metastatic colorectal cancer (mCRC) by comparing progression-free survival (PFS) on TP compared to control arm (Arm 2) of cetuximab and irinotecan hydrochloride (irinotecan) (CETIRI). SECONDARY OBJECTIVES: I. To evaluate the overall response rate (ORR), including confirmed complete and partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, in treatment Arms 1 and 2. II. To evaluate the overall survival (OS) in treatment Arms 1 and 2. III. To evaluate the safety and toxicity of TP compared to CETIRI. TERTIARY OBJECTIVES: I. To estimate the rates of PFS, OS, and ORR in patients who crossover to TP (Arm 3) after disease progression on CETIRI. II. To bank images for future retrospective analysis. III. To evaluate if HER-2/centromeric probe (CEP17) signal ratio and HER-2 gene copy number (GCN) are predictive of clinical efficacy for patients receiving TP versus CETIRI. IV. To bank tissue and blood samples for other future correlative studies from patients enrolled on the study. OUTLINE: Patients with HER2 gene amplification are randomized to 1 of 2 arms. ARM I: Patients receive pertuzumab intravenously (IV) over 30-60 minutes and trastuzumab IV over 30-120 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive cetuximab IV over 60-120 minutes and irinotecan hydrochloride IV over 90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may optionally crossover to Arm I. After completion of study treatment, patients are followed up for 3 years. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Carcinoma
  • Colon Adenocarcinoma
  • Colonic Neoplasms
  • ERBB2 Gene Amplification
  • Rectal Adenocarcinoma
  • Rectal Neoplasms
  • Recurrence
  • Recurrent Colon Carcinoma
  • Recurrent Rectal Carcinoma
  • Stage III Colon Cancer AJCC v7
  • Stage III Rectal Cancer AJCC v7
  • Stage IIIA Colon Cancer AJCC v7
  • Stage IIIA Rectal Cancer AJCC v7
  • Stage IIIB Colon Cancer AJCC v7
  • Stage IIIB Rectal Cancer AJCC v7
  • Stage IIIC Colon Cancer AJCC v7
  • Stage IIIC Rectal Cancer AJCC v7
  • Stage IV Colon Cancer AJCC v7
  • Stage IV Rectal Cancer AJCC v7
  • Stage IVA Colon Cancer AJCC v7
  • Stage IVA Rectal Cancer AJCC v7
  • Stage IVB Colon Cancer AJCC v7
  • Stage IVB Rectal Cancer AJCC v7

NCT number NCT03365882
Study type Interventional
Source SWOG Cancer Research Network
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 27, 2017
Completion date November 20, 2024

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