Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy

NCT00336856 | Completed Phase 2 Results DMC

• 1 other identifier: 06-006
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer; Rectum Cancer

Keywords

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate (RR)

  Percentage of partial responses (PR) + complete responses (CR).

  every 6 - 8 weeks, up to 30 months

Secondary Outcomes (2)

• Time to Progression

  Up to 30 months

• Overall Survival

  Up to 30 months

Study Arms (1)

IRINOTECAN AND CETUXIMAB

EXPERIMENTAL

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.

Drug: Cetuximab; Drug: Irinotecan

Interventions

Cetuximab DRUG

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.

IRINOTECAN AND CETUXIMAB

Irinotecan DRUG

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.

IRINOTECAN AND CETUXIMAB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Eastern Cooperative Oncology Group (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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Cetuximab; Irinotecan

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Nathan Bahary, MD
• Organization: University of Pittsburgh

baharyn@upmc.edu

412-864-7764

Study Officials

• Nathan Bahary, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2006
• First Posted: June 14, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 12, 2016
• Results First Posted: July 12, 2016

Record last verified: 2016-06

Locations

US (1)