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Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

bevacizumab

capecitabine

fluorouracil

irinotecan hydrochloride

diagnostic laboratory biomarker analysis

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the colon or rectum
- Previously untreated metastatic disease
Measurable disease by RECIST
- Must not be located in a prior radiation field
No cerebral or meningeal metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

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

Exclusion criteria:

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:

Inclusion criteria:

See Disease Characteristics

Exclusion criteria:

Prior adjuvant bevacizumab or irinotecan hydrochloride
Concurrent aspirin (> 325 mg/day) or therapeutic anticoagulants
Surgery in the past 28 days

Sites / Locations

Centre Hospitalier Regional de Besancon - Hopital Jean MinjozRecruiting

Outcomes

Primary Outcome Measures

Objective response (complete and partial) rate

Secondary Outcome Measures

Progression-free survival

Overall survival

Tolerance

Resectability rate

Biomarkers predictive of efficacy

Full Information

NCT ID

NCT00544011

First Posted

October 13, 2007

Last Updated

June 23, 2011

Sponsor

Hopital Jean Minjoz

1. Study Identification

Unique Protocol Identification Number

NCT00544011

Brief Title

Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Official Title

Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

April 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hopital Jean Minjoz

4. Oversight

5. Study Description

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.

Detailed Description

OBJECTIVES: Primary Evaluate the objective response (complete and partial) rate in patients with metastatic colorectal adenocarcinoma treated with bevacizumab and modified FOLFIRI 3 chemotherapy. Secondary Determine progression-free and overall survival. Determine the tolerance to this regimen. Evaluate the resectability rate. Evaluate biological markers predictive of the efficacy of this regimen. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1, irinotecan hydrochloride IV over 90 minutes on days 1 and 3, and fluorouracil IV continuously over 46 hours on day 1. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. At 14 days after completing chemotherapy, patients with progressive or stable disease receive maintenance therapy comprising bevacizumab and capecitabine. Biological specimens are collected at baseline and before the fourth course of chemotherapy. After completion of study therapy, patients are followed every 3 months for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Allocation

Non-Randomized

Enrollment

47 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

bevacizumab

Intervention Type

Drug

Intervention Name(s)

capecitabine

Intervention Type

Drug

Intervention Name(s)

fluorouracil

Intervention Type

Drug

Intervention Name(s)

irinotecan hydrochloride

Intervention Type

Other

Intervention Name(s)

diagnostic laboratory biomarker analysis

Primary Outcome Measure Information:

Title

Objective response (complete and partial) rate

Secondary Outcome Measure Information:

Title

Progression-free survival

Title

Overall survival

Title

Tolerance

Title

Resectability rate

Title

Biomarkers predictive of efficacy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum Previously untreated metastatic disease Measurable disease by RECIST Must not be located in a prior radiation field No cerebral or meningeal metastases PATIENT CHARACTERISTICS: Inclusion criteria: 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 Exclusion criteria: 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: Inclusion criteria: See Disease Characteristics Exclusion criteria: Prior adjuvant bevacizumab or irinotecan hydrochloride Concurrent aspirin (> 325 mg/day) or therapeutic anticoagulants Surgery in the past 28 days

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christophe Borg, PhD

Organizational Affiliation

Hopital Jean Minjoz

Facility Information:

Facility Name

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

City

Besancon

ZIP/Postal Code

25030

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christophe Borg, PhD

Phone

33-381-668-705

christophe.borg@efs.sante.fr

12. IPD Sharing Statement

Citations:

PubMed Identifier

27472156

Citation

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.

Results Reference

derived

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Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

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