Clinical trial NCT00717990: Irinotecan, Capecitabine and Avastin for Metastatic Colorectal Cancer as Salvage Treatment
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Colorectal cancer
Bevacizumab
XELIRI
Lead sponsor: University Hospital of Crete
Sponsor class: OTHER
First posted: 2008-07-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of Irinotecan,Capecitabine and Avastin combination in patients with no response to previous treatment with 5-Fluorouracil,Leucovorin,Eloxatin and Avastin.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: up to 6 months
Secondary outcomes:
measure: Time To Progression
timeFrame: 1 year
measure: Toxicity profile
timeFrame: Toxicity assessment on each chemotherapy
measure: Quality of life
timeFrame: Assessment every two cycles
measure: Symptoms improvement
timeFrame: Assessment every two cycles
measure: Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete, Dep of Medical Oncology
Study officials:
affiliation: University Hospital of Crete, Dep of Medical Oncology
name: Vassilis Georgoulias, MD
role: PRINCIPAL_INVESTIGATOR
References: