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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01532804
First Posted: February 15, 2012
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle
  Purpose
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.

Condition Intervention Phase
Metastatic Colorectal Cancer Drug: bevacizumab, oxaliplatin and 5FU combination Drug: Bevacizumab, oxaliplatin and raltitrexed combination Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Institut du Cancer de Montpellier - Val d'Aurelle:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 6 months ]
    DFS is estimated from the date of randomization until the first date of objectively documented event or death


Secondary Outcome Measures:
  • Treatment-related toxicity [ Time Frame: 6 months ]
    Treatment-related toxicity is evaluated according to the NCI-CTCAE v.4 criteria.

  • Objective response rate [ Time Frame: Every 9 weeks ]
    Objective response rate is evaluated according to the RECIST V 1.1 criteria.

  • Overall survival [ Time Frame: unk ]
    OS is estimated from the date of randomization until the date of death from any cause

  • Cost-effectiveness study [ Time Frame: 6 months ]
    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 [ Time Frame: 6 months ]
    Quality of life is measured using the QLQ-C30 questionnaire


Enrollment: 83
Study Start Date: July 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
FOLFOX6 + bevacizumab (D1=D15, 12 cycles)
Drug: bevacizumab, oxaliplatin and 5FU combination

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)

Experimental: Arm B
Raltitrexed + Oxaliplatin + Bevacizumab (D1=D21, 8 cycles)
Drug: Bevacizumab, oxaliplatin and raltitrexed combination

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


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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532804


Locations
France
Val d'Aurelle Cancer Institute
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Principal Investigator: Emmanuelle Samalin-Scalzi, MD Val d'Aurelle Cancer Institute
  More Information

Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT01532804     History of Changes
Other Study ID Numbers: BEVATOMOX
2010-023447-15 ( EudraCT Number )
First Submitted: February 10, 2012
First Posted: February 15, 2012
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
Unresectable metastases

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
Bevacizumab
Oxaliplatin
Raltitrexed
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Enzyme Inhibitors