Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of Rectum

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Bristol-Myers Squibb
ImClone LLC
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00580073
First received: December 17, 2007
Last updated: October 15, 2010
Last verified: October 2010
  Purpose

This study involves the use of Oxaliplatin, 5-Fluorouracil (5-FU), Leucovorin and Cetuximab, which are all medicines approved by the Food and Drug Administration (FDA) and are commercially available. This treatment regimen will possibly be combined with radiation before and/or after surgery depending on your response to the treatment. Their use in this exact combination is considered experimental. The purpose of this study is to find out how effective this combination of chemotherapy is as treatment for rectal cancer that has not spread to other parts of the body. The side effects and survival experienced by subjects receiving these drugs will also be evaluated. This is a phase II research study.


Condition Intervention Phase
Rectal Cancer
Drug: FOLFOX4
Drug: Cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of the Rectum

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • response to therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: December 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
FOLFOX4 + Cetuximab
Drug: FOLFOX4
oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
Other Name: Oxaliplatin (Eloxatin), 5FU (5-Fluorouracil) and Leucovorin (Folinic Acid)
Drug: Cetuximab
Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle.
Other Name: Cetuximab (C225, Erbitux)

Detailed Description:

Primary Objective:

- Down-staging of the tumor

Secondary Objectives:

  • Pathologic response rate
  • Tumor marker response
  • Incidence of sphincter sparing surgery
  • Progression-free survival
  • Overall Survival
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients must have newly diagnosed, histologically proven adenocarcinoma of the rectum. Locally advanced T3, T4 or any T with N1, N2, staged by trans-rectal ultrasound.
  • All patients must have an abdominal/pelvis CT scan or MRI confirming no evidence of distant metastases.
  • Patients must have an ECOG PS ≤ 2
  • Patient has signed informed consent
  • Lower Age Limit: 18 years
  • Upper Age Limit: No upper age limit
  • Laboratory parameters:

    • Hgb: > 9.0 g/dl
    • ANC >1500/ul
    • Platelet >100,000/ul
    • Creatinine < 2x ULN
    • Bilirubin < 2x ULN
    • ALT < 2x ULN

Exclusion Criteria:

  • Administration of any prior systemic anticancer therapy for colorectal cancer (eg, chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, angiogenesis inhibitors).
  • Previous intra-arterial cytotoxic chemotherapy given as treatment for colorectal cancer.
  • Previous pelvic radiotherapy.
  • Known allergy or intolerance to oxaliplatin, 5-FU, cetuximab or leucovorin.
  • Pregnant or breast-feeding women: female patients must agree to use effective contraception, must be surgically sterile, or must be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. All at-risk female patients must have a negative serum pregnancy test within 7 days prior to registration.
  • Active inflammatory bowel disease, significant bowel obstruction, or chronic diarrhea (grade 2).
  • Myocardial infarction or stroke within the previous 6 months, or ongoing unstable angina, symptomatic congestive heart failure, or serious uncontrolled cardiac dysrhythmia.
  • Known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness.
  • No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which the patient has been disease-free for 3 years.
  • Known CNS metastases
  • Preexisting neuropathy > Grade 2
  • Prior therapy which specifically and directly targets the EGFR pathway
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580073

Locations
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Sanofi
Bristol-Myers Squibb
ImClone LLC
Investigators
Study Chair: Michael Huie, M.D. UW Paul P. Carbone Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Daniel Mulkerin, M.D., UW Paul P. Carbone Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00580073     History of Changes
Other Study ID Numbers: 2007-0197 (CO06207)
Study First Received: December 17, 2007
Last Updated: October 15, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Cetuximab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014