Irinotecan, Capecitabine and Avastin for Metastatic Colorectal Cancer as Salvage Treatment
This study is currently recruiting participants.
Verified July 2011 by University Hospital of Crete
Sponsor:
University Hospital of Crete
Information provided by:
University Hospital of Crete
ClinicalTrials.gov Identifier:
NCT00717990
First received: July 16, 2008
Last updated: March 13, 2012
Last verified: July 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Metastatic Colorectal Cancer |
Drug: Capecitabine Drug: Bevacizumab Drug: Irinotecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by University Hospital of Crete:
Primary Outcome Measures:
- Objective Response Rate [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time To Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
- Symptoms improvement [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 35 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
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| Ages Eligible for Study: | 18 Years to 72 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717990
Contacts
| Contact: Dora Hatzidaki | +302810392570 | dorachat@med@uoc.gr |
| Contact: Eva Maragkoudaki | +302810392857 | dorachat@med.uoc.gr |
Locations
| Greece | |
| University Hospital of Crete, Dep of Medical Oncology | Recruiting |
| Heraklion, Greece | |
| Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr | |
| Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr | |
| Sub-Investigator: Nikos Vardakis, MD | |
Sponsors and Collaborators
University Hospital of Crete
Investigators
| Principal Investigator: | Vassilis Georgoulias, MD | University Hospital of Crete, Dep of Medical Oncology |
More Information
No publications provided
| Responsible Party: | V.Georgoulias, University Hospital of Crete |
| ClinicalTrials.gov Identifier: | NCT00717990 History of Changes |
| Other Study ID Numbers: | CT/05.35 |
| Study First Received: | July 16, 2008 |
| Last Updated: | March 13, 2012 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by 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 Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Irinotecan Capecitabine Bevacizumab Fluorouracil |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors Angiogenesis Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013