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Dual Inhibition of EGFR Signalling Using the Combination of Cetuximab (Erbitux) and Erlotinib (Tarceva) in Patients With Chemotherapy-refractory Colorectal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

Dual Inhibition of EGFR Signalling Using the Combination of Cetuximab (Erbitux) and Erlotinib (Tarceva) in Patients With Chemotherapy-refractory Colorectal Cancer


Inclusion Criteria:



- Age>18 years

- Histological diagnosis of colorectal cancer

- Metastatic disease not amenable to resection

- Measurable disease as assessed by CT scan using RECIST criteria

- Received and failed fluoropyrimidine therapy, where failure is defined as
radiological progression after therapy for metastatic disease, prior adjuvant
therapy, or toxicity limiting further therapy

- Received and failed oxaliplatin therapy, where failure is defined as radiological
progression after therapy for metastatic disease, prior adjuvant therapy ,or
toxicity (including neuro-toxicity) limiting further therapy

- Received and failed irinotecan therapy, where failure is defined as radiological
progression after therapy for metastatic disease or toxicity limiting further
therapy

- ECOG PS 0-1

- Adequate bone marrow function with platelets > 100 X 109/l; neutrophils > 1.5 X 109/l

- Adequate renal function, with calculated creatinine clearance >40 ml/min (Cockcroft
and Gault).

- Adequate hepatic function with serum total bilirubin < 1.25 X upper limit of normal
range and ALT or AST<2.5xULN (<5xULN if liver metastases present)

- Life expectancy of at least 12 weeks

- No other concurrent uncontrolled medical conditions

- No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ
of the uterine cervix or any other cancer treated with curative intent >2 years
previously without evidence of relapse

- Women and partners of women of childbearing potential must agree to use adequate
contraception

- Written informed consent including consent for biomarker studies

Exclusion Criteria:

- Medical or psychiatric conditions that compromise the patient's ability to give
informed consent or to complete the protocol

- Prior treatment with drugs targeting EGFR such as cetuximab, panitumumab or erlotinib

- Participation in any investigational drug study within the previous 4 weeks

- Patients with uncontrolled clinically significant cardiac disease, arrhythmias or
angina pectoris

- Untreated CNS metastases

- Pregnancy or lactation

- k-ras mutant tumours now excluded

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the response rate (RECIST criteria). Responses will be evaluated for the whole patient group and separately for k-ras wild-type and k-ras mutant tumours

Outcome Time Frame:

6 weekly

Safety Issue:

No

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

H2008/03282

NCT ID:

NCT00784667

Start Date:

October 2008

Completion Date:

February 2011

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal neoplasm
  • Metastasis
  • Colorectal Neoplasms

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