Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00551421
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage III Colon Cancer
  • Stage III Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pertuzumab — BIOLOGICAL
    Given IV
  • cetuximab — BIOLOGICAL
    Given IV
  • irinotecan hydrochloride — DRUG
    Given IV
  • immunohistochemistry staining method — OTHER
    Correlative study
  • fluorescence in situ hybridization — OTHER
    Correlative study
  • gene expression analysis — OTHER
    Correlative study
  • mutation analysis — OTHER
    Correlative study
  • polymerase chain reaction — OTHER
    Correlative study
  • laboratory biomarker analysis — OTHER
    Correlative study

Study Details

Monoclonal antibodies, such as pertuzumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving pertuzumab together with cetuximab may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of pertuzumab when given together with cetuximab and to see how well they work in treating patients with previously treated locally advanced or metastatic colorectal cancer

Key Dates

Start date
Oct 31, 2007
Status verified
Jul 2014
Primary completion
Nov 30, 2010
Completion
Jun 30, 2012

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).

Primary Outcome Measure

Recommended Phase II Dose of Pertuzumab When Administered in Combination With Cetuximab (Phase I) [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MA

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