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A Phase 2 Study of Irinotecan and Cetuximab on an Every 2 Week Schedule, as Second Line Therapy in Patients With Advanced Colorectal Cancer

Phase 2
18 Years
Open (Enrolling)
Colon Cancer, Rectum Cancer

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Trial Information

A Phase 2 Study of Irinotecan and Cetuximab on an Every 2 Week Schedule, as Second Line Therapy in Patients With Advanced Colorectal Cancer

Primary Objective:

┬ĚThe primary aim of this study is to assess the response rate of patients with previously
treated CRC Number of Subjects: 31

Study Population:

Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen
containing oxaliplatin and a fluoropyrimidine, and who have not previously received
irinotecan or cetuximab for treatment of CRC.

Test Product, Dose and Mode of Administration, Duration of Treatment:

Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes,
followed by 500 mg/m2 every 2 weeks IV over 60 minutes.

Reference Therapy, Dose and Mode of Administration, Duration of Treatment: Irinotecan
administered at a dose of 150a or 180 mg/m2 IV over 60 minutes every two weeks.

Inclusion Criteria:

- Patients must consent to be in the study

- Patients must have advanced, surgically unresectable CRC, who have failed a first
line metastatic regimen, within 12 months of starting protocol therapy.

- Patients must have measurable disease

- There must be histologic confirmation of adenocarcinoma of the colon or rectum.

- Patients must have an ECOG performance status of 0, 1, or 2

- Estimated life expectancy of at least 12 weeks.

- One prior therapy for metastatic disease is permitted.

- Recurrence within 12 months of adjuvant therapy with FOLFOX or a similar regimen (i.e
FLOX, CapOX) is considered one regimen and allowed for study

- There must be evidence of adequate organ function

- Patients with a history of prior non-colorectal malignancies are eligible if they
have been disease-free for ┬│ 5 years prior to study entry and are deemed by the
physician to be at low risk for recurrence.

- Age > 18 yrs.

Exclusion Criteria:

- Any prior therapy with irinotecan or cetuximab or an EGFR targeting agent.

- Any systemic therapy administered for metastatic or locally recurrent colorectal
cancer within 28 days of study treatment.

- Patients who are considered candidates for surgical resection of metastatic and/or
locally advanced disease.

- Any histology other than adenocarcinoma of the colon or rectum.

- Serious concomitant medical conditions that, in the opinion of the investigator,
would compromise the safety of the patient or compromise the patient's ability to
complete the study.

- Evidence of central nervous system metastases

- Pulmonary fibrosis or interstitial pneumonitis

- General Medical Concerns

- History of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates the use of an investigational drug or that might affect the
interpretation of the results of the study or render the subject at high risk from
treatment complications.

- Serious, uncontrolled, concurrent infection.

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, or anticipation of need for major surgical procedure during the
course of the study; fine needle aspirations or core biopsies within 7 days prior to
Day 0. Line placement (i.e Infus-a-port or PICC) is not considered major surgery.

- Evidence of bleeding diathesis or coagulopathy

- Prior severe infusion reaction to a monoclonal antibody.

- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled
congestive heart failure, and cardiomyopathy with decreased ejection fraction.

- Patients with Gilbert's Syndrome

- Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of
the importance of avoiding pregnancy during trial participation and the potential
risk factors for an unintentional pregnancy. In addition, men enrolled on this study
should understand the risks to any sexual partner of childbearing potential and
should practice an effective method of birth control.

- All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving
investigational product. If the pregnancy test is positive, the patient must not
receive investigational product and must not be enrolled in the study.

- In addition, all WOCBP should be instructed to contact the Investigator immediately
if they suspect they might be pregnant (e.g., missed or late menstrual period) at any
time during study participation.

- The Investigator must immediately notify BMS in the event of a confirmed pregnancy in
a patient participating in the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the response rate of patients with previously treated CRC

Outcome Time Frame:

every 6 - 8 weeks

Safety Issue:


Principal Investigator

Nathan Bahary, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

July 2011

Related Keywords:

  • Colon Cancer
  • Rectum Cancer
  • Colon Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms



UPMC Cancer Centers Pittsburgh, Pennsylvania  15232