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A Parallel Phase II Study With Irinotecan/Cetuximab (Until PD) Followed by XELOX/Cetuximab (Until PD) vs the Reverse Sequence in Metastatic CRC With Previous Benefit on Irinotecan/Bevacizumab Based Therapy


Phase 2
18 Years
72 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

A Parallel Phase II Study With Irinotecan/Cetuximab (Until PD) Followed by XELOX/Cetuximab (Until PD) vs the Reverse Sequence in Metastatic CRC With Previous Benefit on Irinotecan/Bevacizumab Based Therapy


Because of the recent advances in the field of systemic chemotherapy for mCRC, like
irinotecan, oxaliplatin, capecitabine, and targeted agents (Cetuximab, Bevacizumab) mCRC
patients have an overall survival that in some cases reaches 25 months.Irinotecan is an
inhibitor of the DNA enzyme topoisomerase I, with use in clinical practice for the last 10
years.In a phase II study with mCRC patients resistant to irinotecan based therapy the
combination of irinotecan and Cetuximab (an IgG1 anti-EGFR antibody) yielded a response rate
of 22.5%.Capecitabine was shown to have improved tolerability and response rate compared
with bolus 5-FU, with comparable time to progression and survival.Oxaliplatin has been
approved by the FDA for 2nd line treatment in the metastatic CRC setting as a number of
trials have shown promising data for response rates, disease stabilization rates,median
progression free survival (PFS) and overall survival (OS).KRAS is a predictive marker for
clinical benefit from EGFR-based antibody treatment. KRAS is the first molecular marker for
selection of a targeted therapy in combination with a standard chemotherapy regimen.
Patients with KRAS wild-type tumors have a strong benefit from the administration of
cetuximab with better PFS and objective responses.


Inclusion Criteria:



- Histologically confirmed locally advanced or metastatic colorectal cancer

- Measurable or evaluable disease according to the Response Evaluation Criteria in
Solid Tumors (RECIST)

- ECOG performance status ≤ 2

- Age 18 - 72 years

- Patients who have had a CR, PR or SD after 1st line therapy based on
Irinotecan+Bevacizumab

- Paraffin block from the primary tumor in order to perform tha mutational analysis of
the KRAS gene

- Adequate liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 4 upper normal limit,
ALP ≤ 2.5 upper normal limit),renal (Creatinine ≤ 1.5 upper normal limit) and bone
marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function

- Patients must be able to understand the nature of this study

- Written informed consent

Exclusion Criteria:

- Presence of central nervous system or brain metastases

- Pregnant or lactating woman

- Life expectancy < 3 months

- Previous radiotherapy within the last 4 weeks or > 25% of bone marrow or in the field
where the treatment target is located

- Peripheral neuropathy grade ≥2

- Known hypersensitivity to Erbitux

- Metastatic infiltration of the liver >50%

- Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction
or total colectomy

- Active infection

- Second primary malignancy, except for non-melanoma skin cancer and in situ cervical
cancer

- Psychiatric illness or social situation that would preclude study compliance

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time To Progression

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

John Souglakos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete

Authority:

Greece: National Organization of Medicines

Study ID:

CT/05.31

NCT ID:

NCT00755534

Start Date:

November 2008

Completion Date:

November 2008

Related Keywords:

  • Colorectal Cancer
  • Metastatic colorectal cancer
  • Second line
  • Irinotecan
  • Cetuximab (Erbitux)
  • Capecitabine (Xeloda)
  • Colorectal Neoplasms

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