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Phase II Open Label Comparative Study of Cetuximab and Radiation Therapy Vs Surgery Before or After Radiation Therapy in Patients With Stage II to IV Colorectal Carcinoma


Phase 2
40 Years
N/A
Not Enrolling
Both
Colorectal Carcinoma

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Trial Information

Phase II Open Label Comparative Study of Cetuximab and Radiation Therapy Vs Surgery Before or After Radiation Therapy in Patients With Stage II to IV Colorectal Carcinoma


OBJECTIVES:

Primary:

- Determine the response rate in patients with Colorectal Cancer treated with Cetuximab
and Radiation Therapy Vs Surgery before or after Radiation Therapy.

Secondary:

- To determine the progression-free survival and overall survival of patients treated
with these regimens.

- Compare the treatment compliance of patients treated with these regimens.

- Compare the safety of these regimens in these patients.

OUTLINE: This is an Open-label, Controlled, Multicenter study. Patients will be assigned
into two different Arms.

Arm I: Patients will receive Cetuximab and Radiation Therapy. Patients will receive a dose
of Cetuximab through Intravenous (IV). The initial dose is 400 mg/m2 administered as a
120-minute intravenous infusion (maximum infusion rate 10 mg/min) and weekly dose is 250
mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or
unacceptable toxicity. Radiation treatment for Colorectal Cancer are Intensity Modulated
Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the
intensity of the radiation with laser accuracy.

Arm II: Patients will undergo surgery before or after Radiation Therapy. Colorectal Cancer
Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and
Radiofrequency ablation. Radiation treatment for Colorectal Cancer are Intensity Modulated
Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the
intensity of the radiation with laser accuracy.

PROJECTED ACCRUAL: Approximately 450 patients will be accrued for this study within 18 to 24
months.


Inclusion Criteria:



- Patients with stage II- IV Colorectal Cancer

- Patients must be 40 years and older

- Patients may be of any race and either gender

- Signed Informed Consent

Patient characteristics:

- Age: 40 years and older

- Sex: Both

- Performance status: Not specified

- Life expectancy: Not specified

Hematopoietic:

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

- No history of significant bleeding events within the past 6 months

Hepatic:

- Bilirubin ≤ 1.5 mg/dL

- Albumin ≥ 2.5 g/dL

Renal:

- Creatinine ≤ 1.5 times upper limit of normal

- Protein < 1+ by urinalysis

- Protein < 1 g by 24-hour urine collection

Cardiovascular:

- No conduction defect in heart

- No congestive heart failure

- No myocardial infarction within last 6 months

- No cerebrovascular accident

- No uncontrolled hypertension

- No clinically significant peripheral artery disease

Pulmonary:

- No pulmonary embolism

- No interstitial pneumonia

- No extensive or symptomatic interstitial fibrosis of the lung

Neurologic:

- No uncontrolled seizure disorder

- No active neurological disease

Other:

- Not pregnant or nursing

- Negative pregnancy test

Exclusion Criteria:

- Age below 40 years

- Brain or nervous system metastases

- Any current mental illness

- Hemoglobin is less than 9.0 g/dl

- CBC results are below normal range

- Patients with Hepatitis B or C or who are HIV positive

- Pregnant or nursing patients are not eligible for entry into the study

- Hepatic abnormality AST/ALT > 4 folds

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response rate

Outcome Time Frame:

4 year

Safety Issue:

Yes

Principal Investigator

Ratna Grewal, MD

Investigator Role:

Study Chair

Investigator Affiliation:

American Scitech International- eCRO

Authority:

United States: Institutional Review Board

Study ID:

ASI-CRO0000192008

NCT ID:

NCT00725400

Start Date:

February 2010

Completion Date:

February 2014

Related Keywords:

  • Colorectal Carcinoma
  • Colorectal Cancer
  • Erbitux
  • Cetuximab
  • Surgery
  • Radiation
  • Carcinoma
  • Colorectal Neoplasms

Name

Location

Practicing physician in New JerseyEnglishtown, New Jersey  07726