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Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Gail Tribble, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00336856
First received: June 12, 2006
Last updated: December 9, 2013
Last verified: December 2013

June 12, 2006
December 9, 2013
June 2006
June 2011   (final data collection date for primary outcome measure)
To assess the response rate of patients with previously treated CRC [ Time Frame: every 6 - 8 weeks ] [ Designated as safety issue: No ]
To assess the response rate of patients with previously treated CRC
Complete list of historical versions of study NCT00336856 on ClinicalTrials.gov Archive Site
  • To measure time to progression [ Time Frame: every 6 - 8 weeks ] [ Designated as safety issue: No ]
  • To measure the duration of response for responding patients. [ Time Frame: every 6 - 8 weeks ] [ Designated as safety issue: No ]
  • To characterize the quantitative and qualitative toxicities in this patient population. [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
  • To study the effect of cetuximab on serial serum EGF levels, over expression of EGFR pathways and downstream markers on tumor tissue (STAT, mutant EGFR and MAPK) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To characterize the pharmacokinetics of cetuximab given on a every 2 week schedule [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • To measure time to progression
  • To measure the duration of response for responding patients.
  • To characterize the quantitative and qualitative toxicities in this patient population.
  • To study the effect of cetuximab on serial serum EGF levels, over expression of EGFR pathways and downstream markers on tumor tissue (STAT, mutant EGFR and MAPK)
  • To characterize the pharmacokinetics of cetuximab given on a every 2 week schedule
Not Provided
Not Provided
 
Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy
A Phase 2 Study of Irinotecan and Cetuximab on an Every 2 Week Schedule, as Second Line Therapy in Patients With Advanced Colorectal Cancer

Research Hypothesis: Subjects in the study population who are treated with cetuximab in combination with irinotecan will have higher response rates than subjects treated with irinotecan alone.

Primary Objective:

·The 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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colon Cancer
  • Rectum Cancer
  • Drug: Cetuximab
    The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks.
  • Drug: Irinotecan
    The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks.
Experimental: IRINOTECAN AND CETUXIMAB
Cetuximab will be administered at the dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks, IV over 2 hours at an infusion rate not to exceed 5 ml/min. Followed immediately by Irinotecan administered at a dose of 180 mg/m2 IV over 60 minutes every two weeks.
Interventions:
  • Drug: Cetuximab
  • Drug: Irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
June 2011
June 2011   (final data collection date for primary outcome measure)

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 ³ 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00336856
06-006
Yes
Gail Tribble, University of Pittsburgh
Gail Tribble
Bristol-Myers Squibb
Principal Investigator: Nathan Bahary, M.D. University of Pittsburgh
University of Pittsburgh
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP