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.
Verified February 2012 by Centre Val d'Aurelle - Paul Lamarque
Sponsor:
Centre Val d'Aurelle - Paul Lamarque
Information provided by (Responsible Party):
Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier:
NCT01532804
First received: February 10, 2012
Last updated: February 14, 2012
Last verified: February 2012
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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 2014 |
| Estimated Primary Completion Date: | July 2013 (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
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 14, 2012 |
| 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 Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Oxaliplatin Raltitrexed Bevacizumab |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013