Gastroenterology&Hepatology– In the Department of Medicine

Jacques Van Dam, M.D., Ph.D.

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Safety Study of Cetuximab in combination with Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer

Contact Information

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Heidi Kaiser (650) 724-0079
To view all clinical trials at Stanford, please see the Clinical Trials Directory.

Brief

1. To determine the MTD and DLTs of oxaliplatin and capecitabine when combined with C225 and radiotherapy (Phase I) 2. To determine the pathologic response rate of C225 in combination with this neoadjuvant cytotoxic regimen (Phase II)

Recruiting Status:

Completed

Stanford Recruiting Status:

Completed

Condition(s):

Intervention(s):

  • Drug: Oxaliplatin
  • Drug: Capecitabine
  • Drug: Cetuximab
  • Procedure: Radiotherapy
  • Procedure: Surgery

Phase:

Phase 1/Phase 2

Eligibility

Ages Eligible for Study:

18 years to Any Age

Genders Eligible for Study:

Male and Female

Health of Volunteers:

People with the conditions listed in this trial can participate as controls.

Key Inclusion Criteria:

- Patients with histologically confirmed adenocarcinoma of the rectum: EUS stage T3 or T4 or N1 disease are eligible (includes T3 N0, T3 N1, T4 N0, T4 N1, T1-4 N1). Rectal cancers will be defined as those whose distal border extends to within 12cm of the anal verge.
- Age >= 18.
- Karnofsky performance status >= 70.
- Creatinine within normal institutional limits or creatinine clearance > 60mL/min/1.73m2 for patients with serum creatinine levels above institutional normal.
- Negative urine pregnancy test if a woman of child bearing potential (WOCBP).
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
- WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the treatment.
- Ability to swallow pills without difficulty.
- No prior pelvic or whole abdominal radiotherapy.
- Patients must have adequate organ and marrow function as defined below:
Leukocyte count > 3,500.
Platelet count > 100,000.
SGOT, SGPT, Alk. Phos: < 2.5x institutional upper limits of normal.
Total bilirubin < 1.5x institutional normal institutional limits.

Key Exclusion Criteria:

- Metastatic (M1) or stage IV disease.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with a concurrent malignancy or previous malignancy within 5 years of screening will be excluded from this study; with the exception of patients with concurrent or previous non-melanoma skin cancer, hematolymphoid malignancy or carcinoma in-situ of the cervix, who may be included at the investigator's discretion.
- WOCBP who is pregnant or breastfeeding.
- A history of C225 or other therapy that targeted the EGF receptor.
- A history of prior anti-cancer murine monoclonal antibody therapy.
- Inability to sign written consent.
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Subjects who are men must also agree to use effective contraception.

Additional Study Details

Official Title:

A Phase I/II Trial of Cetuximab in Combination with Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgical Resection for Locally-Advanced Rectal Cancer

Anticipated start date:

6/8/2004

Lead Sponsor:

Stanford University

Collaborator(s):

  • Bristol-Myers Squibb

Investigator(s):

Study Type:

Interventional

Purpose:

Treatment

Allocation:

Randomized

Masking:

Open

Control:

none

Assignment:

Single Group

Endpoints:

Unspecified

Primary Outcomes:

  • To determine the MTD and DLTs of oxaliplatin and capecitabine when combined with C225 and radiotherapy (Phase I)
  • 2. To determine the pathologic response rate, at the time of surgical resection, of C225 in combination with this neoadjuvant cytotoxic regimen (Phase II).

Secondary Outcomes:

  • 1. To determine the effect of EGFR inhibition on immunohistochemical markers of downstream pathways (e.g. p27, MAP-K), apoptosis, and angiogenesis.
  • 2. To determine additional efficacy endpoints including downstaging, local relapse rate and survival, and time-to-progression in patients treated with the treatment regimen described above.
  • 3. To determine the toxicity associated with this treatment and to document perioperative morbidity.

Total Number to be Enrolled:

60

Total Number to be Enrolled at Stanford:

60

More Information

Trial Unique Id: COR0001

Secondary ID(s):

  • 95054
  • COR0001
  • NCT00226941

Locations & Contacts

Stanford Locations & Contacts:

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Heidi Kaiser (650) 724-0079

Non-Stanford Locations:

The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.

This listing was last updated:

4/27/2009

PLEASE NOTE:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.

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