Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC
This study has been completed.
Sponsor:
Hellenic Oncology Research Group
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00469443
First received: May 3, 2007
Last updated: August 18, 2010
Last verified: August 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: Irinotecan Drug: 5-Fluorouracil Drug: Leucovorin Drug: Capecitabine Drug: Bevacizumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Study of Irinotecan Plus 5-fluorouracil Plus Leucovorin and Bevacizumab (FOLFIRI+Avastin) Versus Irinotecan Plus Capecitabine and Bevacizumab (XELIRI+Avastin) as 1st Line Treatment of Locally Advanced or Metastatic Colorectal Cancer |
Resource links provided by NLM:
Drug Information available for:
Fluorouracil
Leucovorin calcium
Levoleucovorin
Irinotecan
Irinotecan hydrochloride
Capecitabine
Bevacizumab
U.S. FDA Resources
Further study details as provided by Hellenic Oncology Research Group:
Primary Outcome Measures:
- Time To Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: Probability of 1-year survival (%) ] [ Designated as safety issue: No ]
- Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ 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 ]
| Estimated Enrollment: | 330 |
| Study Start Date: | December 2006 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
FOLFIRI/Avastin
|
Drug: Irinotecan
Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles
Other Name: CPT-11
Drug: 5-Fluorouracil
5-Fluorouracil 400 mg/m2 infused over 10 min IV and 5-FU 600 mg/m2 infused over 22 hours IV, on Day 1 and 2 (De Grammont regimen), every 2 weeks for 10 cycles
Other Name: 5-FU
Drug: Leucovorin
Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles
Other Name: LV
Drug: Bevacizumab
Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles
Other Name: Avastin
|
|
Experimental: 2
XELIRI/Avastin
|
Drug: Capecitabine
Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
Other Name: Xeloda
Drug: Bevacizumab
Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles
Other Name: Avastin
Drug: Irinotecan
Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles
Other Name: CPT-11
|
Detailed Description:
There is no data of comparison for Folfiri and Xeliri regimens. The reported data demonstrated that the addition of Avastin in the combination of irinotecan/bolus 5-FU/LV has significant improvement of overall survival. Further analysis of these results showed that patients receiving irinotecan in combination with Avastin, as 1st line treatment and oxaliplatin with Avastin, as second line treatment, have median overall survival 25, 1 months, which is the longest survival that has been reported.
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
- ECOG performance status ≤ 2
- Age 18 - 72 years
- Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function
- Patients with history of hemoptysis or with increased risk of thromboembolic events should be observed carefully due to administration of Avastin
- Patients must be able to understand the nature of this study
- Written informed consent
Exclusion Criteria:
- Previous 1st line chemotherapy
- Adjuvant chemotherapy with Irinotecan regimen with relapse < 6 months after the completion
- Active infection
- History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- Previous radiotherapy within the last 4 weeks or > 25% of bone marrow
- Patients with unstable CNS metastases
- Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction
- Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
- Psychiatric illness or social situation that would preclude study compliance
- Pregnant or lactating women
- Patients > 65 years with history of arterial thromboembolic, myocardial infarction, unstable angina and pulmonary embolism
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469443
Locations
| Greece | |
| University General Hospital of Alexandroupolis, Dep of Medical Oncology | |
| Alexandroupolis, Greece | |
| "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | |
| Athens, Greece | |
| 401 Military Hospital of Athens | |
| Athens, Greece | |
| "IASO" General Hospital of Athens, 1st Dep of Medical Oncology | |
| Athens, Greece | |
| Air Forces Military Hospital of Athens | |
| Athens, Greece | |
| State General Hospital of Larissa | |
| Larissa, Greece | |
| "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology | |
| Piraeus, Greece | |
| "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology | |
| Thessaloniki, Greece | |
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
| Principal Investigator: | John Souglakos, MD | johnsougl@gmail.com |
More Information
No publications provided by Hellenic Oncology Research Group
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | J.Sougklakos, Hellenic Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT00469443 History of Changes |
| Other Study ID Numbers: | CT/05.16 |
| Study First Received: | May 3, 2007 |
| Last Updated: | August 18, 2010 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by Hellenic Oncology Research Group:
|
Metastatic colorectal cancer Irinotecan Capecitabine Bevacizumab |
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 Fluorouracil Capecitabine Irinotecan Bevacizumab |
Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 21, 2013