Irinotecan, Capecitabine and Avastin for Metastatic Colorectal Cancer as Salvage Treatment

• ClinicalTrials.gov Identifier: NCT00717990
• Recruitment Status: Terminated
• First Posted: July 18, 2008
• Last Update Posted: October 7, 2015
• Sponsor: University Hospital of Crete
• Information provided by (Responsible Party): Vassilis Georgoulias, MD, University Hospital of Crete

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metastatic Colorectal Cancer	Drug: Capecitabine; Drug: Bevacizumab; Drug: Irinotecan	Phase 2

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: 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 Start Date: April 2008
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; XELIRI/Avastin	Drug: Capecitabine; Capecitabine 2000 mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles; Other Name: Xeloda; Drug: Bevacizumab; Bevacizumab 7.5 mg/kg intravenous (IV) on day 1 every 3 weeks for 6 cycles; Other Name: Avastin; Drug: Irinotecan; Irinotecan 250 mg/m2 IV on day 1 every 3 weeks for 6 cycles; Other Names: Campto; CPT-11

Outcome Measures

Primary Outcome Measures :

1. Objective Response Rate [ Time Frame: up to 6 months ]

Secondary Outcome Measures :

1. Time To Progression [ Time Frame: 1 year ]
2. Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy ]
3. Quality of life [ Time Frame: Assessment every two cycles ]
4. Symptoms improvement [ Time Frame: Assessment every two cycles ]
5. Overall Survival [ Time Frame: 1 year ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 72 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Greece

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Greece

Sponsors and Collaborators

University Hospital of Crete

Investigators

• Principal Investigator: Vassilis Georgoulias, MD; University Hospital of Crete, Dep of Medical Oncology

More Information

• Responsible Party: Vassilis Georgoulias, MD, MD, University Hospital of Crete
• ClinicalTrials.gov Identifier: NCT00717990 History of Changes
• Other Study ID Numbers: CT/05.35
• First Posted: July 18, 2008
• Last Update Posted: October 7, 2015
• Last Verified: October 2015

Keywords provided by Vassilis Georgoulias, MD, University Hospital of Crete:

Colorectal cancer; Bevacizumab; XELIRI

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Capecitabine; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Bevacizumab; Irinotecan; Antineoplastic Agents, Immunological; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors