Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Trial Evaluating Raltitrexed, Oxaliplatin and Bevacizumab Combination Versus FOLFOX6 Plus Bevacizumab in 2nd-line Treatment of Metastatic Colorectal Cancer (BEVATOMOX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Centre Val d'Aurelle - Paul Lamarque
Sponsor:
Information provided by (Responsible Party):
Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier:
NCT01532804
First received: February 10, 2012
Last updated: February 4, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Centre Val d'Aurelle - Paul Lamarque:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Treatment-related toxicity is evaluated according to the NCI-CTCAE v.4 criteria.

  • Objective response rate [ Time Frame: Every 9 weeks ] [ Designated as safety issue: No ]
    Objective response rate is evaluated according to the RECIST V 1.1 criteria.

  • Overall survival [ Time Frame: unk ] [ Designated as safety issue: No ]
    OS is estimated from the date of randomization until the date of death from any cause

  • Cost-effectiveness study [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Quality of life is measured using the QLQ-C30 questionnaire


Estimated Enrollment: 124
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532804

Contacts
Contact: Jean-Pierre Bleuse, MD + 33 4 67 61 23 44 Jean-Pierre.Bleuse@montpellier.unicancer.fr

Locations
France
Val d'Aurelle Cancer Institute Recruiting
Montpellier, France, 34298
Contact: Emmanuelle Samalin-Scalzi, MD    + 33 4 67 61 25 92    Emmanuelle.Samalin@montpellier.unicancer.fr   
Principal Investigator: Emmanuelle Samalin-Scalzi, MD         
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Investigators
Principal Investigator: Emmanuelle Samalin-Scalzi, MD Val d'Aurelle Cancer Institute
  More Information

No publications provided

Responsible Party: Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier: NCT01532804     History of Changes
Other Study ID Numbers: BEVATOMOX, 2010-023447-15
Study First Received: February 10, 2012
Last Updated: February 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Val d'Aurelle - Paul Lamarque:
Unresectable metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Bevacizumab
Oxaliplatin
Raltitrexed
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014