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Open Label, Multicenter, Phase II Study Evaluating the Efficacy and Safety of IMC-11F8 in Combination With 5-FU/FA and Oxaliplatin (mFOLFOX-6) in Patients With Treatment-naïve, Locally-advanced or Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer

Thank you

Trial Information

Open Label, Multicenter, Phase II Study Evaluating the Efficacy and Safety of IMC-11F8 in Combination With 5-FU/FA and Oxaliplatin (mFOLFOX-6) in Patients With Treatment-naïve, Locally-advanced or Metastatic Colorectal Cancer


The purpose of this study is to evaluate the anti-tumor activity (best overall response) of
the anti-EGFR monoclonal antibody IMC-11F8 administered in combination with mFOLFOX-6
chemotherapy regimen in treatment-naive, locally-advanced or metastatic colorectal cancer
patients.


Inclusion Criteria:



- Histologically-confirmed, EGFR-detectable or EGFR-undetectable colorectal cancer

- Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum

- At least one unidimensional-measurable target lesion by CT scan or MRI; target
lesion(s) must not lie within an irradiated area

- Age ≥ 18 years

- Life expectancy of ≥ 6 months

- ECOG performance status ≤ 2 at study entry

- Adequate hematologic function, as evidenced by an ANC ≥ 1.5 x 10^9 L, hemoglobin ≥ 10
g/dL, and platelets ≥ 100 x 10^9/L

- Adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, AST and ALT ≤
2.5 x ULN, and alkaline phosphatase ≤ 2.5 x ULN (or 5.0 x ULN in the case of liver
metastases)

- Adequate renal function as defined by a serum creatinine ≤ 1.5 x ULN, creatinine
clearance ≥ 60 mL/min, or serum albumin ≥ LLN

- Patient's relevant toxicities/effects of prior therapy (surgery/RT) must have
recovered to a stable or chronic level

- Patient agrees to use adequate contraception during the study period and for 4 weeks
after the last dose of study treatment. Patients must notify the principal
investigator if they themselves or their partner becomes pregnant.

- Patient has provided signed informed consent

Exclusion Criteria:

- Has received prior systemic chemotherapy for locally-advanced unresectable or
metastatic CRC.

- Has received prior radiotherapy to > 25% of bone marrow

- Has documented and/or symptomatic brain metastases

- Has participated in clinical studies of non-approved experimental agents or
procedures within 12 weeks of study entry

- Has received previous therapy with monoclonal antibodies

- Has received previous therapy with any agent that targets the epidermal growth factor
receptor

- Has serious concomitant medical conditions including active uncontrolled infection or
cardiac disease, which in the opinion of the investigator, could compromise the
patient or study.

- On chronic non-topical corticosteroid treatment for > 6 months at doses > 10 mg/day
of prednisolone or equivalent before study entry, which in the opinion of the
investigator could compromise the patient or the study

- Has a known dihydropyrimidine dehydrogenase deficiency

- Has a known allergy to any of the treatment components

- Has an acute or subacute intestinal occlusion

- Has peripheral neuropathy ≥ grade 2

- Has a history of other malignancies, with the exception of curatively treated
non-melanoma skin cancer or carcinoma in situ of the cervix

- If female, is pregnant (confirmed by urine or serum beta human chorionic gonadotropin
test) or breast-feeding

- Has received a prior autologous or allogeneic organ or tissue transplantation

- Has interstitial pneumonia or interstitial fibrosis of the lung

- Has pleural effusion or ascites that causes ≥ grade 2 dyspnea

- Has psychological, familial, sociological, or geographical conditions which do not
permit adequate study follow-up, compliance with the protocol, or signature of
Informed Consent

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response (OOR)

Outcome Time Frame:

Approximately 30 Months

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Chair

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

13926

NCT ID:

NCT00835185

Start Date:

August 2007

Completion Date:

October 2010

Related Keywords:

  • Metastatic Colorectal Cancer
  • Antibodies, Monoclonal
  • Colorectal Neoplasms
  • Colorectal Neoplasms

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