NCT00544011

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well bevacizumab given together with combination chemotherapy works in treating patients with metastatic colorectal cancer.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
Last Updated

June 27, 2011

Status Verified

July 1, 2009

First QC Date

October 13, 2007

Last Update Submit

June 23, 2011

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

  • Objective response (complete and partial) rate

Secondary Outcomes (5)

  • Progression-free survival

  • Overall survival

  • Tolerance

  • Resectability rate

  • Biomarkers predictive of efficacy

Interventions

bevacizumabBIOLOGICAL
capecitabineDRUG
fluorouracilDRUG
irinotecan hydrochlorideDRUG
diagnostic laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • WHO performance status 0-1
  • Life expectancy \> 12 weeks
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Transaminases ≤ 2 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases present)
  • Creatinine ≤ 130 μmol/L OR creatinine clearance ≥ 30 mL/min
  • Proteinuria \< 2+ or urine protein ≤ 1 g/24 hours
  • Not pregnant or nursing
  • Fertile patients of must use effective contraception

You may not qualify if:

  • Uncontrolled cardiac disease
  • Prior cerebral vascular accident
  • Uncontrolled arterial hypertension
  • Severe renal or hepatic insufficiency
  • Prior arteriopathy
  • Bleeding disorder or nonhealing wound
  • Coagulopathy
  • Other malignancy within the past 2 years except basal cell or squamous cell skin cancer or curatively treated carcinoma of the cervix
  • Psychiatric disorder compromising comprehension or participation in the study
  • Intestinal occlusion or subocclusion not caused by medical therapy
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Prior adjuvant bevacizumab or irinotecan hydrochloride
  • Concurrent aspirin (\> 325 mg/day) or therapeutic anticoagulants
  • Surgery in the past 28 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

RECRUITING

Related Publications (1)

  • Jary M, Lecomte T, Bouche O, Kim S, Dobi E, Queiroz L, Ghiringhelli F, Etienne H, Leger J, Godet Y, Balland J, Lakkis Z, Adotevi O, Bonnetain F, Borg C, Vernerey D. Prognostic value of baseline seric Syndecan-1 in initially unresectable metastatic colorectal cancer patients: a simple biological score. Int J Cancer. 2016 Nov 15;139(10):2325-35. doi: 10.1002/ijc.30367. Epub 2016 Aug 13.

    PMID: 27472156DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

BevacizumabCapecitabineFluorouracilIrinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCamptothecinAlkaloids

Study Officials

  • Christophe Borg, PhD

    Hopital Jean Minjoz

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2007

First Posted

October 16, 2007

Study Start

April 1, 2007

Last Updated

June 27, 2011

Record last verified: 2009-07

Locations

FR(1)