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A Phase II Study of Irinotecan, Capecitabine and Avastin in Patients With Metastatic Colorectal Cancer, Who Have Progressed After 1ST Line Therapy With Folfox/Avastin.


Phase 2
18 Years
72 Years
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

A Phase II Study of Irinotecan, Capecitabine and Avastin in Patients With Metastatic Colorectal Cancer, Who Have Progressed After 1ST Line Therapy With Folfox/Avastin.


The aim of this phase II study is to evaluate the efficacy of the combination XELIRI/AVASTIN
in patients with mCRC, who have progressed in first line treatment with FOLFOX/AVASTIN. For
AVASTIN was selected the dosing schedule of the trials TREE 1 and 2 [17], where Avastin was
combined with capecitabine and oxaliplatin in a three weeks schedule and with adaptation of
the dose in the 7,5 mg/kg


Inclusion Criteria:



- Histologically confirmed locally advanced or metastatic colorectal cancer

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

- ECOG performance status ≤ 2

- Age 18 - 72 years

- Patients who progress after 1st line therapy with FOLFOX/AVASTIN

- 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:

- History of serious cardiac disease (unstable angina, congestive heart
failure,uncontrolled cardiac arrhythmias)

- History of myocardial infarction or stroke within 6 months

- Clinically significant peripheral vascular disease

- History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess
within 28 days prior to Day 0

- Major surgical procedure, open biopsy, or significant traumatic injury within 30 days
prior to Day 1

- Presence of central nervous system or brain metastasis

- Evidence of bleeding diathesis or coagulopathy

- Blood pressure > 150/100 mmHg

- Pregnant or lactating woman

- Life expectancy < 3 months

- Previous radiotherapy within the last 4 weeks or > 25% of bone marrow

- Metastatic infiltration of the liver > 50%

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

- Active infection requiring antibiotics on Day 1

- 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:

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

Outcome Measure:

Objective Response Rate

Outcome Time Frame:

up to 6 months

Safety Issue:

No

Principal Investigator

Vassilis Georgoulias, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete, Dep of Medical Oncology

Authority:

Greece: National Organization of Medicines

Study ID:

CT/05.35

NCT ID:

NCT00717990

Start Date:

April 2008

Completion Date:

December 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal cancer
  • Bevacizumab
  • XELIRI
  • Colorectal Neoplasms

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