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2nd-line Treatment of Metastatic Colorectal Cancer (BEVATOMOX)

Primary Purpose

Metastatic Colorectal Cancer

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
bevacizumab, oxaliplatin and 5FU combination
Bevacizumab, oxaliplatin and raltitrexed combination
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Unresectable metastases

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically proven colorectal cancer
  • Resected or asymptomatic primary tumor
  • Metastatic colorectal cancer not eligible for curative surgery
  • No major surgery within four weeks of the start of study treatment
  • At least one target lesion unidimensionally measurable on cross-sectional imaging according to RECIST criteria (v1.1)
  • Disease progression after failure of irinotecan-based chemotherapy
  • Bone metastases are allowed if there is at least one other measurable metastatic site
  • CT scan of the abdomen, chest and pelvis within 3 weeks of the start of study treatment
  • WHO PS ≤ 2
  • Platelet count >= 100,000 mm3
  • Hemoglobin > 10g/dl
  • Bilirubin < 1.5 ULN, AST/ALT < 5 ULN
  • Serum creatinine < 1.5 ULN, creatinine clearance > 60 ml/min (Cockcroft)
  • A time period of 4 weeks should be respected between the end of previous treatments and study enrollment
  • Negative pregnancy test in women of childbearing potential
  • Male or female using an effective contraceptive method
  • Absence of known or symptomatic brain metastases
  • Life expectancy > 3 months
  • Informed consent signed prior any study specific procedures

Exclusion Criteria:

  • Prior raltitrexed-based chemotherapy
  • Prior oxaliplatin-based chemotherapy (except for adjuvant treatment completed for more than 6 months)
  • Uncontrolled arterial hypertension defined as systolic pressure > 150 mm Hg or diastolic pressure > 100 mm Hg
  • Malignant hypertension or hypertensive encephalopathy
  • Myocardial infarction, pulmonary embolism, or severe vascular disease within 6 months prior to study entry
  • Hemorrhagic diathesis or significant pathology of coagulation
  • Peripheral neuropathy grade>2 (NCI-CTC v4.0)
  • Hemoptysis < 1 month
  • Venous access device (PAC) or any other minor surgery such as a biopsy within the last 7 days
  • Symptomatic brain metastases or carcinomatous meningitis
  • History or presence of other cancer within the past 5 years (except curatively treated nonmelanoma skin cancer and in situ cervical cancer)
  • Severe bacterial or fungal infection (Grade > 2 NCI-CTCAE v.4.0)
  • Known or suspected sensitivity to one of the study drugs
  • Pregnant or breastfeeding women
  • Previous enrollment in an investigational drug study within the last 4 weeks
  • Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up)

Sites / Locations

  • Val d'Aurelle Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm Description

FOLFOX6 + bevacizumab (D1=D15, 12 cycles)

Raltitrexed + Oxaliplatin + Bevacizumab (D1=D21, 8 cycles)

Outcomes

Primary Outcome Measures

Disease-free survival
DFS is estimated from the date of randomization until the first date of objectively documented event or death

Secondary Outcome Measures

Treatment-related toxicity
Treatment-related toxicity is evaluated according to the NCI-CTCAE v.4 criteria.
Objective response rate
Objective response rate is evaluated according to the RECIST V 1.1 criteria.
Overall survival
OS is estimated from the date of randomization until the date of death from any cause
Cost-effectiveness study
The cost-effectiveness study includes the number of hospital stays (treatment and toxicity), the global cost of treatments, and the cost of hospital stays due to treatment-induced toxicity
Quality of life by using the quality of life questionnaire score
Quality of life is measured using the QLQ-C30 questionnaire

Full Information

First Posted
February 10, 2012
Last Updated
December 24, 2019
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT01532804
Brief Title
2nd-line Treatment of Metastatic Colorectal Cancer
Acronym
BEVATOMOX
Official Title
A Multicenter Randomized Phase 2 Trial to Evaluate the Triplet Combination of Raltitrexed, Oxaliplatin and Bevacizumab Versus FOLFOX6 Plus Bevacizumab in Second-line Treatment of Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
too slow recruiting
Study Start Date
July 28, 2011 (Actual)
Primary Completion Date
May 12, 2016 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.
Detailed Description
Eligible patients are randomly allocated to receive either bevacizumab with raltitrexed and oxaliplatin combination or bevacizumab with FOLFOX 6 combination. Random allocation schedule is performed using a minimization technique for the following stratification factors: Center Number of metastatic sites: 1 versus > 1 Bevacizumab-based first-line therapy: Yes versus No

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Unresectable metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
FOLFOX6 + bevacizumab (D1=D15, 12 cycles)
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Raltitrexed + Oxaliplatin + Bevacizumab (D1=D21, 8 cycles)
Intervention Type
Drug
Intervention Name(s)
bevacizumab, oxaliplatin and 5FU combination
Intervention Description
Bevacizumab 5 mg/kg administered as an iv infusion for 1h30, then for 1h and for 30 min. at the following cycles, respectively. Oxaliplatin 85 mg/m² administered as an iv infusion for 2h Elvorine 200 mg/m² administered as an iv infusion for 2h 5FU 400 mg/m2 bolus then 5FU 2,400 mg/m² iv infusion for 46h D1=D15 (12 cycles)
Intervention Type
Drug
Intervention Name(s)
Bevacizumab, oxaliplatin and raltitrexed combination
Intervention Description
Bevacizumab 7.5 mg/kg administered as an iv infusion for 1h30, then administered for 1h and 30 min at the following cycles, respectively. Oxaliplatin 130 mg/m² administered as an iv infusion for 2h Raltitrexed 3 mg/m² administered as an iv infusion for 15 min
Primary Outcome Measure Information:
Title
Disease-free survival
Description
DFS is estimated from the date of randomization until the first date of objectively documented event or death
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Treatment-related toxicity
Description
Treatment-related toxicity is evaluated according to the NCI-CTCAE v.4 criteria.
Time Frame
6 months
Title
Objective response rate
Description
Objective response rate is evaluated according to the RECIST V 1.1 criteria.
Time Frame
Every 9 weeks
Title
Overall survival
Description
OS is estimated from the date of randomization until the date of death from any cause
Time Frame
unk
Title
Cost-effectiveness study
Description
The cost-effectiveness study includes the number of hospital stays (treatment and toxicity), the global cost of treatments, and the cost of hospital stays due to treatment-induced toxicity
Time Frame
6 months
Title
Quality of life by using the quality of life questionnaire score
Description
Quality of life is measured using the QLQ-C30 questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven colorectal cancer Resected or asymptomatic primary tumor Metastatic colorectal cancer not eligible for curative surgery No major surgery within four weeks of the start of study treatment At least one target lesion unidimensionally measurable on cross-sectional imaging according to RECIST criteria (v1.1) Disease progression after failure of irinotecan-based chemotherapy Bone metastases are allowed if there is at least one other measurable metastatic site CT scan of the abdomen, chest and pelvis within 3 weeks of the start of study treatment WHO PS ≤ 2 Platelet count >= 100,000 mm3 Hemoglobin > 10g/dl Bilirubin < 1.5 ULN, AST/ALT < 5 ULN Serum creatinine < 1.5 ULN, creatinine clearance > 60 ml/min (Cockcroft) A time period of 4 weeks should be respected between the end of previous treatments and study enrollment Negative pregnancy test in women of childbearing potential Male or female using an effective contraceptive method Absence of known or symptomatic brain metastases Life expectancy > 3 months Informed consent signed prior any study specific procedures Exclusion Criteria: Prior raltitrexed-based chemotherapy Prior oxaliplatin-based chemotherapy (except for adjuvant treatment completed for more than 6 months) Uncontrolled arterial hypertension defined as systolic pressure > 150 mm Hg or diastolic pressure > 100 mm Hg Malignant hypertension or hypertensive encephalopathy Myocardial infarction, pulmonary embolism, or severe vascular disease within 6 months prior to study entry Hemorrhagic diathesis or significant pathology of coagulation Peripheral neuropathy grade>2 (NCI-CTC v4.0) Hemoptysis < 1 month Venous access device (PAC) or any other minor surgery such as a biopsy within the last 7 days Symptomatic brain metastases or carcinomatous meningitis History or presence of other cancer within the past 5 years (except curatively treated nonmelanoma skin cancer and in situ cervical cancer) Severe bacterial or fungal infection (Grade > 2 NCI-CTCAE v.4.0) Known or suspected sensitivity to one of the study drugs Pregnant or breastfeeding women Previous enrollment in an investigational drug study within the last 4 weeks Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuelle Samalin-Scalzi, MD
Organizational Affiliation
Val d'Aurelle Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Val d'Aurelle Cancer Institute
City
Montpellier
ZIP/Postal Code
34298
Country
France

12. IPD Sharing Statement

Learn more about this trial

2nd-line Treatment of Metastatic Colorectal Cancer

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